GxP Audit Coordinator 1216576
Company: Stratacuity: Proven Scientific Placement
Posted on: January 12, 2022
Job Scope & Purpose:Our Cambridge based biotech client is
seeking a GxP Audit Coordinator! This role can be remote. Reporting
to the Associate Director, GxP Audit and Inspection Management, you
will be responsible for providing support for the GxP audit
program. Coordinating activities for audit scheduling, process
improvement and facilitate third party auditors in planning.
Collaborating with teams to ensure audit needs are identified and
met. You will be responsible for supporting the GxP audit and
inspection program through coordination of program development and
other tasks for the quality system department, as needed.
Primary Job Responsibilities:
- Support audit program activities including scheduling audits,
assist in trending outcomes, building program audit tools, and
support the development of audit program activities.
- Support and effectuate an annual GxP audit plan in
collaboration with Quality Assurance supporting CMC, Donation
Operations, R&D and Clinical.
- Support tracking and trending activities.
- Coordinate and support process improvement initiatives and
inspection activities.Primary Job Requirements:
- Minimum 3 years of experience in the pharmaceutical or
- GCP experience is a plus
- Knowledge and demonstrated experience in the applicable GXP
regulations, FDA ICH Guidelines.
- Demonstrated ability to effectively organize and execute
- Strong verbal and written communication (including
presentation) and customer management skills.About
Stratacuity:Whether you are seeking a career change or simply
interested in becoming part of our network, you will appreciate the
ethics guiding each Stratacuity team member. We build lasting
relationships with exceptional biopharmaceutical talent and take
great care to protect your personal information. Upon receiving
your inquiry, you may be directly contacted by a Stratacuity team
member to discuss your career goals. We will not share your
information with anyone without your direct prior consent.PROVEN
SCIENTIFIC PLACEMENT---Stratacuity is an Equal Employment
Opportunity/Affirmative Action Employer. All qualified applicants
will receive consideration for employment without regard to race,
color, religion, sex, age, sexual orientation, gender identity,
national origin, disability, protected veteran status, or any other
characteristic protected by law. Stratacuity will consider
qualified applicants with criminal histories in a manner consistent
with the requirements of applicable law. If you have visited our
website in search of information on employment opportunities or to
apply for a position, and you require an accommodation in using our
website for a search or application, please contact us.
Keywords: Stratacuity: Proven Scientific Placement, Cambridge , GxP Audit Coordinator 1216576, Accounting, Auditing , Cambridge, Massachusetts
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