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Compliance
Associate I
A pharmaceutical company located in Northern New Jersey
is seeking a Compliance Associate I whom will be responsible
for coordination of activities relating to receipt,
investigation, response and tracking of product complaints
and Adverse Drug Events with associated product complaints.
Duties and Responsibilities:
-Coordinate all activities relating to documenting,
investigating, and responding to product technical complaints
and Adverse Drug Events associated with product complaints.
These activities include: performing appropriate investigational
actions, coordinating retrieval of complaint samples
from the field, interacting with supporting functional
departments in gathering and formatting investigation
results, tracking the status of individual product complaints,
preparing written company responses, and assuring that
all activities are completed within SOP required timeframes.
-Act as the primary interface with 3rd party complaint
intake/medical information call center for consumer
drug product complaints and non-medical product inquiries.
-Document and forward complaints and drug product inquiries
that are not originally received through 3rd party complaint
intake/medical information call center.
-Evaluate, input and maintain electronic records and
documentation archives for product complaints in TrackWise
software's complaints module.
-Generate periodic product complaint status reports
detailing open and closed product complaints.
-Identify complaint trends, performing routine analysis
and generating periodic management complaint trending
reports using analytical software/databases.
-Support Quality Management on a project basis as needed.
Education/Experience Requirements:
-B.S. in Human Health or Sciences or equivalent relevant
work experience in the pharmaceutical or other similar
regulated industry (i.e. biologics or medical devices).
-0-3 years experience in a production or quality position
in the pharmaceutical or other regulated industry.
-Excellent written and oral communication skills.
-Proficiency in data trend analysis and database software
packages preferred
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Senior
Clinical Quality Assurance Associate
A known branded global pharmaceutical company in the
Northern NJ area experiencing explosive growth seeks
a Sr. Clinical Quality Assurance Associate to conduct
clinical investigator site audits and other quality
audits, as needed, of internal/external systems, vendors
& clinical documentation to ensure trials are performed
& data are generated, documented (recorded) and
reported with Good Clinical Practices (GCPs) and applicable
regulatory requirements. Write comprehensive audit reports.
Attend International Project Team & study-specific
team meetings. Assist in the development of global &
regional Standard Operating Procedures for Clinical
Quality Assurance. Position requires 30% domestic &
international travel.
BS required in a scientific discipline with 2-5 years
experience in a clinical research or quality role, specifically
dealing with GCP's. In order for consideration candidates
must have experience in the pharmaceutical industry
or in a CRO and prior Clinical Quality Assurance auditing
and regulatory experience. Strong knowledge of GCP guidelines
and federal regulations and of the conduct & phases
of clinical trails in humans. Prior experience with
clinical and regulatory documents
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Quality
Assurance Manager, Clinical Trials and Commercialization
A pharmaceutical company located in Connecticut is
seeking a Quality Assurance Manager, Clinical Trials
and Commercialization. The QA Manager is the critical
decision maker regarding compliance requirements for
all issues involved with the manufacture and secondary
packaging of clinical supplies. He/she will establish,
develop, and ensure Quality Assurance standards are
followed in clinical trials through the review of protocols/
documents/regulations/policies and audit findings. He/she
will be responsible for all Quality issues/questions/inquiries
pertaining to clinical trials, including responses to
European QP comments and questions concerning product
release documentation. The Manager will also schedule
external audits, review audit findings, and coordinate/communicate
to other QA functional groups all required documents,
audits and product release timelines as determined by
corporate objectives. Finally, he/she will coordinate
the release of drug product to meet clinical trial timelines,
will approve clinical trial labeling, and process, monitor
and investigate product complaints as per procedures
and regulations.
Requirements:
Requires a BS degree in a related field and a minimum
of 10 years of relevant experience. Will consider candidates
with an equivalent combination of training and experience.
Knowledge and experience in Phase 1, 2 and 3 clinical
trial supply and requirements, and a working understanding
of cGMP Parts 210 and 211 as they pertain to commercialization.
Must be detail oriented and possess strong oral and
written communication skills, strong interpersonal skills
and superior organizational abilities. Experience with
Microsoft Office, Word, Excel and PowerPoint also required.
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Manager,
Clinical Quality Assurance
Job Description
Independently conduct/lead audits of the internal or
external (vendor) systems, process & documentation
that support clinical research with regard to cGxP compliance,
corporate policy and industry best practice
Responsible for keeping current on regulations and providing
guidance to operational areas on validating computer
systems to ensure compliance with 21 CFR Part 11
Career path is to Sr. Manager, Associate Director and
Director of Clinical QA
Qualifications
Bachelors degree in Computer Science or Life Sciences
is required
4-7 years experience in an FDA regulated industry must
know 21 CFR Part 11 and computer systems validation
Strong organizational and communication skills
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Director,
Developmental Quality Assurance
A pharmaceutical Company in New Jersey seeks a Director,
Developmental Quality Assurance to supports all quality
assurance related matters effecting, and involved with,
the development of drug products. The incumbent will
be responsible for identification and application of
all quality and compliance related regulatory requirements
to the development effort. Assures quality and compliance
requirements are achieved for all GLP/GCP/GMP standards
for new chemical entities, drug products, etc. Working
as a key member of the development team, the incumbent
will identify, and help address any process quality
or reliability issues. The incumbent will be a subject
matter expert on all information regarding quality and
compliance requirements, necessary to contribute to
the successful regulatory approvals of the team's developmental
efforts.
Responsibilities include, but are not limited to, the
following:
1. Supervision of, and review/approval of qualification
activities for all developmental contract manufacturing
organizations and vendors. Develops good follow-up programs
and monitors actions of contractors and vendors as they
complete any necessary corrective actions identified
in audit reports.
2. Responsible to review and approve Master Batch Records
for API drug products used at or
contractor sites.
3. Responsible for API and drug product batch record
review and disposition for all development products,
for all materials for any study (GLP/GCP/GMP).
4. Coordination, review, circulation and recommendation
(to supervisor) of approval, or rejection of, any necessary
or related OOS reports.
5. Assures effective process controls/specification
are in place including follow-up for any additional
data/info deemed necessary by the incumbent, or the
development team. Responsible for archiving and distribution
of such data/info, as necessary.
6. Reviews and approves change controls for API and
drug product manufacturing processes and procedures,
analytical procedures, and related batch records/testing
sop's; assures appropriate reports are issued, approved
and implemented.
7. Coordination, review, circulation and recommendation
(to supervisor) of approval, or rejection of, any necessary
or related reports (OOS, Deviation investigations, etc.)
8. Develops validation protocols for new, or changes
to existing, manufacturing and testing procedures; is
one of the final parties to review and make recommendation
(to supervisor) to approve final reports.
9. Advises the development team on necessary requirements
to approve process changes.
10. Archives developmental API and drug product info/data
for processing, packaging and testing.
11. Assembles and submits relevant QA info and data
to the Regulatory Affairs CMC function for development
of CMC section of NDA.
12. Reviews and makes recommendation (to supervisor)
to approve final CMC section prior to submission to
regulatory bodies.
Requirements:
BS or MS in science, nursing or medically related field.
4+ years Quality
experience, 3-5 Manufacturing experience in a Pharmaceutical
company or other
related industry.
Skills/Knowledge Required:
" Must have 2-3 years direct accountability for
the effective evaluation and release of clinical supply
materials
for toxicological and human clinical studies. Demonstrated
knowledge of GLP/GCP/GMP standards and
practices as they relate to site initiation, maintenance
and drug product accountability.
" Expert level of understanding of drug development
(sterile and non-sterile), clinical study support, and
knowledge of Regulatory requirements, esp. cGMP.
" Must have at least 4 years Quality experience
in a Pharmaceutical company or other related industry.
" Must have 3-5 years Manufacturing experience
in a Pharmaceutical company or other related industry.
" Proficient in statistical analysis, sampling
plans, and AQL's for various defects, etc.
" Must have a BS or MS in science, nursing, or
medically related field.
" Demonstrated track record of success working
on multiple new products development and introductions
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Manager/Senior
Manager, Contract Manufacturing - Quality
Pharmaceutical company located in Northern NJ is seeking
a Manager/Senior Manager, Contract Manufacturing to
manage and direct the activities of the Quality Assurance
Department in regards to third party manufacturers to
ensure compliance with all FDA requirements. Determines
objectives, strategies, systems and procedures for the
oversight of third party manufacturers by the QA department.
Coordinates with appropriate departments within and
outside the company to ensure that compliance objectives
are met.
Duties and Responsibilities
1. Develops and improves Quality Agreements with contract
manufacturers, to assure that product is produced efficiently
and in agreement with Quality requirements.
2. Interfaces with other departments as needed such
as Purchasing, Operations, Planning, Information Systems,
Compliance, Regulatory, Warehousing and QC to understand
needs and to be able to construct workable systems that
relate to and support contract manufacturing quality.
3. Develops and revises Standard Operating Procedures
as needed.
4. Develops and/or evaluates investigative reports in
regards to contract manufacturing Quality requirements.
5. Attends standing meetings such as New Product Launch
(NPL) and Change Control to represent Quality Assurance
Operations.
6. Is responsible for oversight of outside contractor
Quality Assurance support activities such as revision
control of master packaging controls, change control,
material specifications and batch records.
7. May assist in audit activities of outside contractors
as needed.
8. Develops and maintains working relationship with
appropriate FDA representatives. Assists as needed with
FDA inspections.
9. Assists internal Quality Initiatives as required.
Education/Experience Requirements:
" Master's degree in related scientific discipline
7 to 10 years of related experience in a Quality Assurance
environment
" Bachelor's degree in related scientific discipline
10 to 12 years of related experience in a Quality Assurance
environment
" Demonstrated management or supervisory experience
with strong interpersonal and influencing skills.
" Excellent written and oral communication skills
with a strong emphasis on organizational capabilities
and external communications.
" Demonstrated flexibility in carrying out various
assignments in a high quality work environment.
" To perform this job successfully, an individual
should have:
o Excellent written and verbal communication skills
o Attention to detail
o Familiarity with Quality concepts and practices
o Proven experience with FDA.
Scope of Responsibility:
This position works directly with all QA / Sales / Business
Development / Regulatory / and Production departments
in regards all contract manufacturing.
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QA
Specialist I/II
Pharmaceutical company located in New York is seeking
a QA Specialist I/II to be responsible for the review
of laboratory documentation generated from the chemical
analysis of samples from R&D studies (Pharmacokinetic,Toxicokinetic,
Stability, etc.) designed to support IND, NDA and ANDA
submissions, supplements and/or amendments.
Description of Duties and Responsibilities:
Review of analytical and/ or bioanalytical method validations,
study reports and all supporting documentation (notebooks,
instrumental printouts, etc.) for accuracy, completeness
and conformance with GLP and/or cGMP requirements as
appropriate.
Where appropriate, the associate will prepare written
reports of audit findings.
Provide support for validation of laboratory computer
systems and equipment.
Obtain commitments for corrective actions and follow
up to verify implementation of any such measures.
Conduct critical phase inspections of laboratory facilities
and processes.
Assist in review and approvals of Computer Systems Validation
project documentation for laboratory systems.
Assist in the review of quality systems
Requirements:
The position requires a minimum of a Bachelors degree
in chemistry or a related area and 3 years experience
in a cGMP/GLP environment.
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Quality Manager
Job Description
A well known branded pharmaceutical company in New Jersey
seeks Quality Manager to ensure the overall quality
control and accuracy of all clinical documents. Review
documents from various sources for accuracy and completion.
Ensure data, tables, charts, statistical analysis, etc.
in documents are valid and that there is a cohesive,
uniform style and language throughout the documents.
The position is responsible for quality control of all
documents written in medical writing (protocols, amendments,
investigator brochures, and clinical study reports).
Ensure all company's documents are of the highest quality
possible.
Qualifications
Bachelor's degree required 5 years experience in the
pharmaceutical industry
Working knowledge of FDA and ICH Guidelines, AMA Style
Guide, Medical Terminology, and relevant company SOPs.
Able to work well in a team environment and function
under tight deadlines
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Associate Manager Compliance (3rd Party Audit)
Pharmaceutical company located in New Jersey has an
opportunity within the Pharmaceutical Sciences Quality
(PSQ) Organization, 3rd Party / CRO / Vendor Program
(will be referred to as "Suppliers"). The
position is an Associate Manager, Compliance and is
within Band Level C and reports directly to the Suppliers
Audit Manager, which in turn reports to the Associate
Director PAI and CMC Quality Audits (PCQA) Group of
PSQ. The position has responsibility for leading audits
of Pharmaceutical Sciences suppliers (manufacturing,
analytical testing and API/raw material/component manufacturers).
Key responsibilities of this position include, but are
not limited to:
" Plans and independently conducts inspections
of Suppliers, supporting all Pharmaceutical Sciences
development projects. Applies knowledge of applicable
regulations/guidelines, technical expertise, management
skills, and quality management and CGMP experience to
assure adherence to company, industry and government
standards and expectations.
" With minimal supervision interprets the impact
of findings and identifies trends of findings as well
as appropriate action items (CAPAs) to resolve compliance
issues. From these assessments, report process improvement
opportunities, to Pharmaceutical Science Management.
These responsibilities apply to Supplier activities
supporting API, raw materials, packaging components
and drug products manufactured/tested by five (5) separate
business units across two (2) FDA-regulated sites.
" Applies technical experience to assess and monitor
the operational performance of the Supplier Group to
ensure adequate training, overall procedural consistency
and to maximize the information provided through the
qualification program and on-going routine audit/inspection
procedures.
" May represent Pharmaceutical Sciences by assisting
the Manager during external (e.g., Lachman, FDA, EU)
and internal (e.g., CQAC) inspections on issues related
to the Supplier Audit program.
In addition, the position is also responsible for the
following functions within the PCQA department:
" Review of Quality Agreements.
" Identifying/implementing compliance improvements
opportunities to fulfill regulatory obligations and
expectations.
" Identifying/implementing operational process
improvement strategies to streamline the Supplier Auditing
Program.
" Assist in developing modules for training of
new hires and act as a training mentor.
" Participate in the development of departmental
SOPs.
" Perform metrics on the effectiveness of the Supplier
audit program.
Position Requirements:
A BA/BS in chemistry/biology/pharmaceutical sciences
or related fields, with approximately 5 years industry
experience with 3 years auditing/compliance experience
in the regulatory compliance environment, and 2 years
of management responsibility or equivalent is required.
Advanced degree, approximately 3 years of industry experience
with 2 years of auditing experience in the regulatory
compliance environment.
" Must be willing to travel world-wide, approximately
25 - 30%.
" Must have a thorough understanding of applicable
regulations/guidelines/ expectations and have a proven
ability to apply them to a Pharmaceutical environment.
" Knowledge of the CMC development and clinical
trial supply chain
" Proven excellence in written and verbal communication
skills.
" Proven ability to implement quality system improvements.
" Proven ability to effect organization development/improve
operational effectiveness.
" Experience of consent decree beneficial.
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Senior
Manager Quality Systems Audit
An expanding pharmaceutical company in New Jersey seeks
a Senior Manager to lead the audit function for the
company's internal and external compliance program to
include current and prospective suppliers of materials
and services used in the manufacturing of drug products
as well as the internal manufacturing systems for cGMP
compliance. Reviewing draft CMC documents for technical
and regulatory compliance prior to submission to FDA.
Individual will lead a group of four to five professionals.
Duties and Responsibilities:
" Schedule, perform, document, report and follow
up on audits of domestic and foreign suppliers of Active
Pharmaceutical Ingredients, excipient materials and
packaging components.
" Schedule, perform, document, report and follow
up on audits of domestic and foreign service providers
including testing laboratories, computer systems providers
and technical or regulatory contract service providers.
" Schedule, perform, document, report and follow
up on audits of domestic and foreign manufacturing service
providers that are being used or considered for use
as processors or packagers of drug product.
" Schedule, perform, document, report and follow
up on audits of internal manufacturing systems at each
of its manufacturing sites.
" Maintain a controlled list of approved suppliers
that have been qualified to provide materials or services
for the production of drug products.
" Review and approve draft CMC documents prior
to submission to FDA to assure technical and regulatory
compliance.
Education/ Experience Requirements:
" A minimum education resulting in a Bachelor's
Degree in Chemistry, Pharmaceuticals, Biology or a related
field.
" A minimum of 7 years in regulatory compliance,
quality assurance or quality control laboratory experience
in the pharmaceutical industry with 5 + years in a supervisory
capacity.
" Experience auditing manufacturing facilities,
equipment, laboratories and service providers.
" A working knowledge of pharmaceutical manufacturing
processes.
" A working knowledge of pharmaceutical testing
laboratory procedures and instruments.
" An intimate knowledge of the current Good Manufacturing
Practices as defined in the code of Federal Regulations
by the U.S. Food and Drug Administration and the ability
to apply that knowledge to assure that providers of
materials and services are compliant.
" Excellent verbal, written and organizational
skills. The position requires that the employee communicate
with internal and external management groups in order
to assure that non compliant conditions noted during
audits are addressed.
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Senior Quality Engineer
A pharmaceutical company located in Florida seek a
Senior Quality Engineer to work individually or in a
team environment identifies and puts into place corrective
actions to address potential or actual process failures(equipment,
procedural, people or materials).
The key role of the position is to ensure that throughout
a product's lifecycle (development through commercialization)
quality is designed into products by understanding and
controlling the processes used to manufacture and test
the product. Assumes responsibility for the development
of metrics that report on the effectiveness of processes,
status of improvement opportunities and progress against
performance objectives. Key interactions and interfaces
are with Production Management, Project Team Leaders
and team members, QA/QC, Pharmaceutical Technology Operations,
Purchasing and material/component/equipment suppliers.
Serves as a mentor to staff members on the use of quality
tools and measures.
Experience:
BA/BS in Engineering, Math or Science
Requires 5 years experience as a Quality Engineer in
a cGMP environment and leadership skills to enable them
to take the lead. Prefer experience in pharmaceutical
tablet manufacturing or tablet development. KT problem
solving certification, Lean Manufacturing/Six Sigma
Training, Supplier Certification. Advanced degree in
Engineering, Science or Math
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Compliance Associate I-III
Primary Job Purpose:
A pharmaceutical company located in New Jersey seeks
a Compliance Associate I-III for coordination of activities
relating to receipt, investigation, response and tracking
of product complaints and Adverse Drug Events with associated
product complaints.
Duties and Responsibilities:
Coordinate all activities relating to documenting,
investigating, and responding to product technical complaints
and Adverse Drug Events associated with product complaints.
These activities include: performing appropriate investigational
actions, coordinating retrieval of complaint samples
from the field, interacting with supporting functional
departments in gathering and formatting investigation
results, tracking the status of individual product complaints,
preparing written company responses, and assuring that
all activities are completed within SOP required timeframes.
Act as the primary interface with 3rd party complaint
intake/medical information call center for consumer
drug product complaints and non-medical product inquiries.
Document and forward complaints and drug product inquiries
that are not originally received through 3rd party complaint
intake/medical information call center.
Evaluate, input and maintain electronic records and
documentation archives for product complaints in TrackWise
software's complaints module.
Generate periodic product complaint status reports
detailing open and closed product complaints.
Identify complaint trends, performing routine analysis
and generating periodic management complaint trending
reports using analytical software/databases.
Train and oversee daily activities of level I &
II compliance associate in the compliance area.
Support Quality Management on a project basis as needed.
Education/Experience Requirements:
B.S. in Human Health or Sciences or equivalent relevant
work experience in the pharmaceutical or other similar
regulated industry (i.e. biologics or medical devices).
0-5 years experience in a production or quality position
in the pharmaceutical or other regulated industry. Prior
work experience in compliant handling is preferred.
Excellent written and oral communication skills.
Proficiency in data trend analysis and database software
packages preferred.
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Associate Director GLP Compliance
A major pharmaceutical company located in Connecticut
that is in the business of providing pharmaceutical
and animal health products that significantly improve
quality of life seeks an Associate Director, GLP Compliance
to assume the following responsibilities.
Establish policies and procedures for compliance evaluation
of FDA-regulated activities in area of responsibility
within R&D. Investigate and resolve compliance issues
noted during audits/inspections
Act as host for regulatory agency inspections (FDA,
EU, etc.) in area of responsibility
Develop and manage programs designed to enhance regulatory
compliance of Quality Systems and foster an environment
for R&D QA personnel to initiate improvements
Participate in meetings between QA and R&D technical
departments to ensure an interdepartmental team approach
in the development of compliance policies and procedures
at R&D
Initiate work-efficiency programs to allow workloads
to be competently and efficiently handled by staff
Monitor and appraise the performance of direct reports,
provide necessary training where required, and maintain
effective communication within area of responsibility
Foster effective and constructive communication and
interaction with client departments. Encourage direct
reports in effective communication with client departments
Identify areas of potential process improvement related
to compliance and take appropriate actions to achieve
the improvements
REQUIREMENTS
M.S. plus 8 years' experience in Pharmaceutical industry,
or B.S. with 10 years' experience in Pharmaceutical
industry
Thorough knowledge of FDA Guidelines and Regulations
in area of responsibility
Excellent written and oral communication skills are
required
Excellent conflict resolution and negotiation skills
are required
Excellent leadership and mentoring skills are necessary
Skills in dealing with other national cultures is a
requirement
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Quality Assurance Compliance Auditor
Biopharmaceutical company located in Connecticut seeks
a Quality Assurance Compliance Auditor. Responsibilities
include:
" Internal Compliance Medical Device/Pharmaceutical
Audits: schedule, perform, writes report and track audit
responses and corrective actions.
" External Compliance Medical Device/Pharmaceutical
Audits: audit vendors and contract lab and/or manufacturing/packaging
facilities. Vendor qualification program activities
and documentation.
" Write/revise quality system documents (SOPs/Plans/Policies)
and assists other departments with designing quality
and compliance into their systems.
" Review of Protocols and Validation Documentation.
" Participates in training personnel in Medical
Device.
" Perform compliance review of new/revised controlled
documents.
" Perform additional duties as needed to support
QA and compliance.
Detail oriented; Working knowledge of Medical device
regulations;
Excellent oral and written communication skills; Knowledgeable
in Microsoft Office computer applications.
Minimum of 5 years of Pharmaceutical Quality Assurance
experience; Knowledge and experience in Medical Device
regulations a Plus; Previous external auditing experience,
minimum 2-5 years.
A BS degree in a related field required with minimum
of 5 years of pharmaceutical experience required.
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Manager, GMP Compliance
A pharmaceutical company located in Connecticut is
actively seeking a GMP Compliance Manager who will coordinate
the activities and schedules of the QA auditing staff
for internal and external compliance audits. This includes,
among other things, the scheduling, performance, reporting
and tracking of audit responses and corrective actions;
vendor, contract lab, and/or manufacturing/packaging
facilities audits; and vendor qualification program
activities and documentation. He/she will write/revise
quality system documents and SOPs/Plans/Policies, and
assist other departments with designing quality and
compliance into their systems. Finally, the Manager
will also be expected to coordinate activities during
regulatory inspections, and participate in training
personnel in cGMP and QSR.
Requires a BS degree in a related field with a minimum
of 5 years of pharmaceutical QA experience. This experience
must include a minimum of 2 to 3 years of previous internal
and external auditing experience, as well as 2 to 3
years of supervisory/managerial experience. Knowledge
and experience in cGMP and Medical Device regulations
a must. Approximately 20% travel.
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QA Audit Manager GCP
Pharmaceutical company located in New Jersey seeks
a Manager, Quality Audit. The Manager of Quality Audit
manages internal/external audits and clinical trial
data for accuracy and compliance with the company's
Standard Operating Procedures and Regulations.
" Assist Director of QA with maintaining the internal
and external audit schedule
" Plan, coordinate and conduct internal/external
audits
" Oversee and Train Quality Assurance Auditor(s)
" Write and communicate audit findings
" Lead the QA group in audit follow up, and CAPA
" Responsible for the tracking of audits
" Administrator for the Quality Assurance audit
tracking database
" Trend analysis of non-conformances
" Perform the QA review of source documents, CRFs
and reports
" Provide QA review of offsite shipments
" Review all associated documentation, e.g. source
documents, for accuracy and conformance
" Write query report to Project Team
" Perform QA designated task regarding data entry
" Act as a resource to staff for imaging issues
and management
" Track and report data errors detected during
review process
" Track and report quality concerns and problems
to the Director of Quality Assurance
" Communicate effectively, verbally and in writing,
with all internal and external clients
" Assist in the review and development of validation
documentation
" Assures that computer systems meet validation
requirements and are 21 CFR 11 compliant.
" Maintain a safe work environment. Reports workplace
hazards immediately
" Responsible for his/her continuing professional
education
" Other duties as assigned by Director, Quality
Assurance
Qualifications:
" Bachelors Degree
" 3-5 years experience in areas of Quality Assurance,
Inspection, Auditing
" Working knowledge of GCP and Quality/Regulatory
Guidelines and understanding of quality control procedures
and acceptance criteria
" Must be computer literate and familiar with most
common software applications like Word, Excel etc.
" Should be able to follow written procedures accurately
" Must possess strong communication skills, and
enjoy the challenge of working in a deadline-driven
environment with a constant flow of work
" Must work well both independently and as a team
player, open minded to training and learning
" Must be very detailed oriented
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Group Leader, Quality Assurance
A leading pharmaceutical company located in New Jersey
is seeking a Group Leader, Quality Assurance to assure
quality assurance support is provided to the Manufacturing
and Development Departments in a prompt, accurate and
complete manner. Maintain and update the company's SOPs.
Monitor (microbial) of the purified water systems utilized
by Contract Manufacturing. Proactively improve and enforce
GMP compliance. Coordinate special projects and meet
deadlines.
1. Interface with Contract Manufacturing and Development
Departments and their customers; coordinate QA/QC activities
for assigned customers and projects.
2. Coordinate the prompt distribution of samples and
documents to assigned customers.
3. Coordinate QA/QC activities for assigned customers:
a. Raw material sampling / testing and the associated
quality control documentation.
b. Batch record issuance and review.
c. Label preparation as required.
d. Finished product sampling / testing and the associated
quality control documentation.
4. Serve as liaison with new customers and clinical
customers on quality issues.
5. Review microbial water test results and compare to
alert/action levels.
6. Investigate and prepare reports for process deviations,
failures, and complaints.
7. Prepare documentation (including writing SOPs, reports,
tables and graphs for trending analysis).
8. Utilize organizational skills to work on routine
and special projects, including required follow-up.
9. Provide training for new and current employees in
QA/QC programs, techniques, responsibilities, operations,
SOPs, and GMP issues.
10. Give presentations at internal GMP training sessions.
11. Assist in cGMP audits and preparation for audits/inspections
at the direction of the Manager.
12. Write, provide input, or review and approve protocols
and reports for validation/qualification, including
equipment installation, operation and performance, facility
or equipment modifications, process, cleaning, and purified
water systems.
13. Review and approve validation documents for other
Departments including Process Automation.
14. Maintain FDA establishment documents, including
reviewing and updating Drug Master File.
15. Serve as backup to Manager for QA issues in Manager's
absence. Represent department at meetings as needed.
16. Be familiar with and perform tasks normally conducted
by the Quality Control and Quality Assurance Technicians.
17. Other activities as assigned by the Manager, Corporate
Compliance.
Requirements: At least 7 years QA experience in the
pharmaceutical industry. Technical degree (minimum B.S.
or B.A.) required. Experience with analytical laboratory
equipment required. Must be organized, detail-oriented,
thorough, self-motivated, cooperative, and have excellent
written and oral communication skills. Ability to be
both a team player and to work independently. Must possess
computer skills including Microsoft Word, Excel.
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Training Specialist, Quality Assurance
A major pharmaceutical company located in New York
is seeking a Training Specialist within Quality Assurance.
This position within the QA PR&D Group will support
the various product development functions (analytical,
method development, stability, bio-analytical and clinical
manufacturing/packaging) in the development, conducting
and administration of an effective and innovative training
program for R&D professionals. Training will have
a strong emphasis on GLP's / GMP's and documentation
practices, and extend into SOP training and technical
issues specific to each group.
" To develop and implement an effective GLP/GMP
training function.
" Aid department management in development of training
programs for job specific training programs.
" Evaluate and benchmark GLP/GMP training programs
within the industry.
" Focus training effort based on results of audit
reports, FDA Guidelines and industry trends.
" Develop and implement effectiveness checks to
assure understanding of training material.
" Begin implementation of training database software
Requirements:
" Bachelor's degree with 5 to 8 years pharmaceutical
experience
" 2-3 years training experience
" Strong first hand knowledge of GLP's/GMP's in
an R&D environment.
" Experienced in developing and conducting training
programs.
" Experience with database management.
" Very strong verbal, written and presentation
skills.
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Director, Quality Assurance
A major pharmaceutical company located in Florida seeks
a Director in Quality Assurance to provide direction,
management, guidance and technical expertise to personnel
who are:
o Directing, and managing implementation of quality
assurance in the pharmaceutical division
o Directs and leads the quality assurance audit program
for the organization
o Directs and leads the batch release program for the
organization including (finished, intermediate, raw
materials and packaging components)
o Directs and leads incoming inspection for the quality
organization
o Identifies trends and notifies the Senior VP of Quality
with trend changes and out of specification data.
o Ensures that quality assurance activities are harmonized
within the quality organization
o Directs and manages all quarantines, holds for the
organization
o Prepares and analyzes company documentation
o Ensures products comply with regulatory requirements
o Uses detailed knowledge of FDA practices to ensure
documentation analysis, integration and reports reflect
quality and accurate data. Directs and develops new
and improved systems for all related quality assurance
processes.
Interact with Senior Vice Presidents, Senior Directors,
Directors and external contract manufacturers as required
to develop and deliver company documentation.
Contacts will include the following:
o Consultants from consulting firms
o Government Authorities (FDA and other regulatory agencies)
o Vendors (Raw Material Suppliers, etc.)
o Professional Organizations (RAPS, etc.)
o Peers, Senior Management, Multi Site Staff
o May act as the Senior Vice President of QA, when designated.
o Effectively leads and directs work within quality
assurance organization.
o Trains all direct reports in quality assurance
o Establishes the strategies and tactical plans for
quality assurance
o Reviews regulatory guideline changes, implements changes
and informs the quality control organization.
o Independently carries out all assignments
o Directs analyzes, manages and maintains and refines
the quality assurance systems
o Direct and ensure staff conduct compliance risk assessments
and analysis
o Direct and lead refinement and further develop processes,
policies and standards and recommendations that address
key business and compliance risk areas
o Develop and oversee delivery of training, education,
and communication campaigns that are designed to support
a company culture of compliance
o Develop and implement systems and processes designed
to measure progress and track compliance issues, exceptions
and deviations.
o Collaborates closely with the Quality Compliance and
Corporate Legal Departments on all subjects that involve
legal analysis and compliance counsel
o Lead and develop the short and long term strategy
for the quality assurance program within the company.
o Develops and conducts quality assurance risk assessments
and analysis.
o Collaborates with operations and compliance organization
to develop, recommend, implement and maintain compliance
policies and standards in coordination with global business
unit management and legal counsel.
o Develops training, education, and communication campaigns
designed to support culture of compliance with the training
organization
o Maintains current working knowledge of applicable
international, federal and state laws and accreditation
standards related to compliance, and monitors advancements
in compliance technologies to ensure organizational
efficiency on compliance.
o Directs organization, teams and peers/coworkers. Is
responsible to establish and maintain performance and
career development plans for directs, indirects and
contractor reports and provide team feedback. Is able
to manage performance effectively and to overcome obstacles.
o Approves meaningful rewards for superior contributions
to the business as per policy.
o Ensures employee development objectives are met providing
developmental and growth opportunities.
Requirements:
PhD, MS, or FDA compliance/compliance systems experience
is strongly preferred, but will consider B.S. degree
in Chemistry, Biochemistry or Microbiology with 15 years
related quality pharmaceutical experience with increasing
levels of responsibility. International exposure, travel
and project experience is desirable.
Knowledge in and the ability to apply project management,
and change management techniques to internal quality
assurance projects.
Demonstrated organization, facilitation, communication,
and presentation skills.
Appreciation of compliance environments and ability
to work effectively with multi-cultural teams in different
locations to ensure compliance.
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Manager, Quality Assurance
A pharmaceutical company located in Florida seeks a
Manager, QA to perform to following duties.
Review and Approve Company SOP's
Review and Approve OOS reports
Review and Approve Validation Reports
Review and Approve Specifications
Review and Approve Master Batch Records
Prepare, Review and Approve QA SOP's and Forms
Facilitate Site Quality Review
Member of assigned New Product teams
Manage the QA Disposition Group
Manage the QA In-Process QA Group
Manage the QA Packaging Group
Train/Certification of Staff
Interact with FDA and other governmental agencies
Identify cGMP's issues and ensure appropriate corrective
actions are taken
Follow-up on HR related issues promptly and properly
Staff department to provide appropriate support to other
departments
Performs additional related work as assigned.
. Will interact with all departments within the organization
as well as outside agencies (such as FDA, DEA etc..)
Maintains communication as to the status of department
performance and issues to QA Director
Support production activities and ensure compliance
to regulations
Reports and provides corrective actions to any deviations
to Management
Follow up to ensure efficient and timely completion
of tasks assigned
Assist Management with multidiscipline team assignments.
Requirements:
A Bachelor's Degree and 5 years of industry or relevant
experience with a minimum 2 years in a Supervisor capacity
or equivalent. Phase 1 (General), Phase 2 (Saftey),
Phase 3 (Review of all QA training modules) and other
SOP's as required
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QUALITY MANAGER, NE MOLDING &
TOOLING
CRITICAL REQUIREMENTS FOR THIS POSITION INCLUDE:
1. 5+ YEARS IN A QUALITY LEADERSHIP ENVIRONMENT (15+
ASSOCIATES)
2. EXPERIENCE IMPLEMENTING & MAINTAINING QUALITY
MANAGEMENT SYSTEMS GEARED AT OPERATOR KNOWLEDGE &
PROCESS IMPROVEMENT.
3. CUSTOMER FOCUS A MUST
4. EXPERIENCE AS A CHANGE-AGENT
5. ABILITY TO WORK CLOSELY WITH AND DEVELOP A COOPERATIVE
RELATIONSHIP WITH THE MANUFACTURING/OPS DEPARTMENT
6. 3+ YEARS EXPERIENCE IN 2 OF 3 OF THE FOLLOWING MARKETS:
a. Automotive: QS9000/16949 (APQP/PPAP)
b. Medical Device: ISO 13485/FDA QSR/cGMP
c. Aerospace: AS9100
7. IN DEPTH KNOWLEDGE OF 8D C/A FOR PROCESS AND PRODUCT
DEFECTS
8. IN DEPTH KNOWLEDGE OF VARIANCE ANALYSIS (CAPABILITY
STUDIES/DOE)
9. 3-5 YEARS EXPERIENCE IN AN INJECTION MOLDING ENVIRONMENT
(PREFER KNOWLEDGE OF DECOUPLED MOLDING)
10. KNOWLEDGE OF METALS/MACHINING A PLUS
11. EXPERIENCE IN AN OPERATIONAL LEADERSHIP POSITION
A PLUS
12. 3-5 YEARS EXPERIENCE USING WORD/OUTLOOK/EXCEL/VISIO/MINITAB/PROJECT/POWERPOINT
13. PREFER KNOWLEDGE OF IQMS AND/OR VISTA
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QA Associate
A well known pharmaceutical company in New York seeks
a Quality professional to answer the following responsibilities:
Perform QA Packaging Activities
a. Perform batch record review
b. Perform deviation investigations
c. Review and approve label copy
d. Perform pre-production and in process inspection
checks
e. Perform sampling of raw materials
Perform Process Improvement Activities
a. Perform procedural and system audits
b. Write departmental SOPs
c. Ensure compliance with Q/A policies, procedures and
standards
d. Review and approve facilities and equipment qualification
protocols
e. Analyzing and troubleshooting problems, identifying
solutions, and recommending and implementing procedures,
systems and/or techniques for resolution.
Requirement:
Bachelor's degree
Knowledge of GMP's; Familiar with pharmaceutical packaging
activities
3- 5 years plus pharmaceutical experience
Must be computer literate, Word, Excel, Power Point
Must be able to interact effectively in a team-based
environment; cooperative; organized; working with attention
to detail, and independently with minimal supervision.
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Senior Quality Engineer
Pharmaceutical company located in Florida is seeking
a Senior Quality Auditor to work individually or in
a team environment identifies and puts into place corrective
actions to address potential or actual process failures
(equipment, procedural, people or materials). The key
role of the position is to ensure that throughout a
product's lifecycle (development through commercialization)
quality is designed into products by understanding and
controlling the processes used to manufacture and test
the product. Assumes responsibility for the development
of metrics that report on the effectiveness of processes,
status of improvement opportunities and progress against
performance objectives. Key interactions and interfaces
are with Production Management, Project Team Leaders
and team members, QA/QC, Pharmaceutical Technology Operations,
Purchasing and material/component/equipment suppliers.
Serves as a mentor to staff members on the use of quality
tools and measures.
Technical Knowledge: ASQ Certified Quality Engineer
Education: BA/BS in Engineering, Math or Science
Experience: Requires 5-7 years experience as a Quality
Engineer in a cGMP environment and leadership skills
to enable them to take the lead. Prefer experience in
pharmaceutical tablet manufacturing or tablet development.
KT problem solving certification, Lean Manufacturing/Six
Sigma Training, Supplier Certification. Advanced degree
in Engineering, Science or Math
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GLP Auditor III-IV
A major pharmaceutical company located in Connecticut
is seeking a GLP Auditor III - IV to conduct GLP compliance
audits and inspections of the Research & Development
facilities involved in the conduct and/or support of
non-clinical laboratory studies to assess compliance
to FDA GLP regulatory requirements.
Conduct GLP compliance audits of R&D contract laboratory
facilities involved in the conduct and/or support of
the company. (BIPI) sponsored non-clinical laboratory
studies to assess compliance to FDA GLP regulatory requirements
Audit non-clinical laboratory study protocols, data
and reports to access compliance to FDA GLP regulatory
requirements
Prepare and issue detailed Question and Answer audit
reports to appropriate personnel, outlining compliance
issues noted during audits and/or inspections
Provide on-going Quality Assurance support of development
projects. Attend Project team meetings to serve as a
regulatory compliance consultant for the Team
Assist in the development and presentation of training
materials for GLP regulatory compliance
REQUIREMENTS:
B.S., B.A. or M.S. in scientific discipline
Minimum of 3-5 years of GLP audit experience with 5-7
years' experience in the pharmaceutical industry (preferably
in Toxicology)
Excellent verbal and written communication skills
Good interpersonal, problem detection, diplomacy and
organizational skills
Detailed working knowledge of US FDA GLP requirements
Proficient in use of MS Office (Word, Excel and Access)
Willingness to travel approximately 20% of the time,
primarily domestic travel
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Quality Systems Auditor/Group Leader
An expanding pharmaceutical company in New Jersey seeks
a Quality Systems Group Leader and Auditor to lead the
audit function for the company's current and prospective
suppliers of materials and services used in the manufacturing
of drug products as well as the internal manufacturing
systems for cGMP compliance. Reviewing draft CMC documents
for technical and regulatory compliance prior to submission
to FDA.
Duties and Responsibilities:
Schedule, perform, document, report and follow up on
audits of domestic and foreign suppliers of Active Pharmaceutical
Ingredients, excipient materials and packaging components.
Schedule, perform, document, report and follow up on
audits of domestic and foreign service providers including
testing laboratories, computer systems providers and
technical or regulatory contract service providers.
Schedule, perform, document, report and follow up on
audits of domestic and foreign manufacturing service
providers that are being used or considered for use
as processors or packagers of drug product.
Schedule, perform, document, report and follow up on
audits of internal manufacturing systems at each of
its manufacturing sites.
Maintain a controlled list of approved suppliers that
have been qualified to provide materials or services
for the production of drug products.
Review and approve draft CMC documents prior to submission
to FDA to assure technical and regulatory compliance.
Education/ Experience Requirements:
A minimum education resulting in a Bachelor's Degree
in Chemistry, Pharmaceuticals, Biology or a related
field.
A minimum of five years in regulatory compliance, quality
assurance or quality control laboratory experience in
the pharmaceutical industry with 3 + years in a supervisory
capacity.
Experience auditing manufacturing facilities, equipment,
laboratories and service providers.
A working knowledge of pharmaceutical manufacturing
processes.
A working knowledge of pharmaceutical testing laboratory
procedures and instruments.
An intimate knowledge of the current Good Manufacturing
Practices as defined in the code of Federal Regulations
by the U.S. Food and Drug Administration and the ability
to apply that knowledge to assure that providers of
materials and services are compliant.
Excellent verbal, written and organizational skills.
The position requires that the employee communicate
with internal and external management groups in order
to assure that non compliant conditions noted during
audits are addressed.
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Quality Assurance Compliance Auditor
A well known pharmaceutical company located in Connecticut
is seeking a Compliance Auditor to schedule and perform
internal and external audits pertaining to (GXP) GMP/medical
device audits, GLP systems, and 21 CFR Part 11; writes
audit reports, and tracks responses and corrective actions.
He/she also audits external vendors, contract labs,
CROs and/or manufacturing/packaging facilities and is
responsible for vendor qualification program activities
and documentation. The Compliance Auditor writes/revises
SOPs, plans and policies, and assists other departments
with designing quality and compliance into their systems.
Requires a BS degree in a related field with a minimum
of 3-5 years of pharmaceutical QA, laboratory or drug
development experience. Knowledge and experience in
GXP regulations a must. Approximately 25% travel.
Prefer local candidates with no relocation requirements.
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Senior Associate, Clinical Quality Assurance
A well known branded global pharmaceutical company in
New Jersey is expanding and seeks a Senior Associate,
Clinical Quality Assurance to conduct clinical investigator
site audits as well as other quality audits of internal/external
systems, vendors, and clinical documentation to ensure
trials are performed and data is generated, documented
(recorded), and reported in compliance with Good Clinical
Practices (GCPs) and applicable regulatory requirements.
Write comprehensive audit reports to summary audit observations.
Attend International Project Team meetings as well as
study specific team meetings. Contribute to the ongoing
development of standardized auditing procedures for
compliance with regulatory expectations. Conduct other
quality audits to assess the effectiveness of, and the
compliance with, policies, processes, procedures, and
data for internal/external systems, vendors, and clinical
documentation
Qualifications
Bachelor's degree, preferably in scientific area
2-5 years of experience in a quality oriented role specifically
dealing with GCP and/or GLP auditing, CRO or pharmaceutical
experience
Strong organizational and time management skills with
the ability to effectively conduct work on multiple
projects
Technical and administrative capabilities to carry out
routine audits with minimal supervision
Ability to travel domestically and/or internationally
at a minimum of 25%
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