Investigation Specialist II

ROLE SUMMARY
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 Investigation Specialist II will join the ACMF Investigations team, conducting GMP investigations including manufacturing deviations, product quality excursions and GMP facility issues.
ROLE RESPONSIBILITIES

• Author manufacturing investigations within Pfizer quality systems.
• Lead routine meetings with record stakeholders (ACMF Operations, Quality Assurance, project teams) to discuss status of open investigations
• Learn, access, and navigate enterprise systems as necessary for information collection (sample management, inventory systems, etc.)
• Manage investigation timelines against product dispositions
• 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 3+ years experience in relevant position (GMP biologics manufacturing, Quality Assurance, scientific roles, etc.)
• Strong technical writing skills
• Proficient in Microsoft Word
• Ability to self-manage timelines and deliverables

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

PHYSICAL/MENTAL REQUIREMENTS
None
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Ability to work in a clean room environment (non-routine)
Work Location Assignment: Flexible
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
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EEO & Employment Eligibility
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Manufacturing