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GxP Audit Coordinator 1216576

Company: Stratacuity: Proven Scientific Placement
Location: Cambridge
Posted on: January 12, 2022

Job Description:

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 biotechnology industry.
    • GCP experience is a plus
    • Knowledge and demonstrated experience in the applicable GXP regulations, FDA ICH Guidelines.
    • Demonstrated ability to effectively organize and execute tasks.
    • 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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