Investigations Associate, ACMF
The Andover Clinical Manufacturing Facility (ACMF) is located on the Pfizer Andover, MA campus and is responsible for the cGMP manufacture of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio.
The Investigations Associate is a new position in the ACMF. Manufacturing investigations are currently written by the ACMF Operations staff. A dedicated Investigations team is being created and will be part of the ACMF Tech Transfer team.
ROLE RESPONSIBILITIES
- Author manufacturing investigations within ACMF quality system
- Author and manage Change Controls for ACMF Operations
- Support audits as needed
- Support other ACMF documentation needs as needed on a non-routine basis (CAS assessments, audit responses, etc.)
BASIC QUALIFICATIONS
- BS/BA in Chemical Engineering, Biotechnology, Microbiology, Cell Biology, Biochemistry or equivalent with 0-3 years of experience in the pharmaceutical industry.
- Advanced technical writing skills
- Proficient in Microsoft Word
- Ability to self-manage timelines and deliverables
- Advanced interview skills
PREFERRED QUALIFICATIONS
- Prior experience writing cGMP manufacturing investigations
- Basic understanding of bioprocessing techniques and equipment
- Experience with Production Control Systems (i.e. DeltaV), ERP Systems (i.e. Microsoft Dynamics and/or SAP) and other business systems (Document Management Systems, LIMS , etc.)
- Demonstrated capability to assemble a matrix cross-functional team
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Ability to work in a clean room environment
Other Job Details:
- Last Date to Apply for Job: January, 18, 2021
- Eligible for Employee Referral Bonus: YES