Quality Assurance Investigations Reviewer

Can work partial remote and onsite

Summary:

The QA Investigations Reviewer is responsible for all QAR-related activities to assure depth and scope of the investigations is adequate to determine root cause and assess product impact, assuring those investigations are completed in a timely manner in compliance with site and corporate cGMP, safety, environmental and human resources policies and procedures.

Responsibilities:

• Perform investigation review and participate on teams investigating laboratory or manufacturing deviations
• Perform initial determination of product impact and determine the type of investigation required
• Participate in investigation teams, ensuring investigation team results and conclusions are documented and supported by data
• Review and approve QARs and all supporting documentation including batch documentation testing results, training records, calibration records, level I and II policies, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents in support of the investigation
• Interact and coordinate with appropriate personnel including manufacturing, clinical, QA/QC, regulatory, technical services, etc.
• Communicate immediately with Quality management for all GMP discrepancies that impact product
• Support lead investigator to identify root causes of the GMP discrepancy by participating in M1s
• Support proposed CAPAs to identified problems
• Assess the impact of discrepancies on products or processes and recommend product disposition
• Ensure clear and concise summaries of investigations, product impact assessments, and commitment
• Participate in cross-functional team reviews to resolve Investigation issues
• Ensure that all SOP mandated timelines are followed including timely completion of QAR/ER commitments which includes verification that all drafting, revising, of change controls, standard operating procedures, testing specifications, batch documentation, training documentation, validation/technical documentation, work orders, purchase orders, AHTs, and others meet the intent of the CAPAs
• Maintain regulatory compliance by initiating investigations as needed and ensuring that all colleagues document all discrepancies and resulting changes, whether process, equipment, or procedural, as per regulatory and company policies

Qualifications:

• BS/BA degree in science/related field with a minimum of 3+ years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry or MS degree in science/related field with some exposure to manufacturing, quality, or engineering experience in the biotech or pharmaceutical industry
• Previous demonstrated experience and expertise in performing or reviewing different types of Investigations (Manufacturing, Laboratory, Engineering, Complaints, and EHS) required
• Experience with relevant QTS modules and QRM practitioner preferred

Please note contractors are engaged to provide services to Pfizer on a temporary basis in connection with a specific assignment. Contractors are hired and employed through Atrium, our third-party payrolling partner.