Quality Assurance Associate

Use Your Power for Purpose 

Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.  

What You Will Achieve 

The Manufacturing Quality Operations Associate provides Quality Assurance (QA) support to all modalities manufactured on site including clinical, commercial, and contract manufacturing operations providing QA Floor oversight. The role ensures adherence to regulatory expectations, safety, and GxP (i.e., Current Good Manufacturing and Documentation Practices). Duties include, but are not limited to, Aseptic Observations, Acceptable Quality Limit (AQL) testing, line clearance approvals, alarms evaluation, on the floor triage, and on the floor real-time batch record review. The Associate will work cross-functionally with MQA Sr. Associates, manufacturing, and support groups to investigate manufacturing events, and support site internal and external regulatory inspections. The role is based at the Pfizer Sanford, NC Pfizer Global Supply (PGS) site. 

In this role, you will: 

• The Manufacturing Quality Operations Associate support includes documentation review, facility walkthrough, support for activities such as review of in-process records, AQL, aseptic observations, compliance walkthroughs, smoke studies, media fills, alarms evaluation, Product Changeovers, etc. 

• Assess manufacturing operations/documentation to ensure proper execution and adherence to Procedures, Regulatory requirements, Safety, Quality Agreement requirements, and Pfizer Quality Standards (PQS) expectations. 

• Work cross-functionally with various business groups (i.e., Operations, Tech Ops, Automation, Compliance, Process Engineering, Investigators, etc.) on manufacturing events to identify root cause(s), aid in the completion of impact assessment, and identification of Corrective/Preventive Action (CAPA). 

• Aid in resolving manufacturing events, and provide opinion, guidance/path-forward. Consults with MQA Sr Associates and/or MQA Manager to align on decisions.  

• Support site regulatory inspections. 

• Facilitate internal & external meetings and provide training/presentations/updates/report-out to QA and Manufacturing colleagues on a regular basis. 

• Suggest Continuous Improvements (CI) initiatives to improve safety and processes and successfully utilize IMEX tools and the “one best way” philosophy. 

• Perform paper/electronic compound batch record review/disposition using computer software applications including, but not limited to: gLIMS, SAP, MES, AMPS, Batch Tracker. 

• Provide guidance/coaching to less experienced QA, Contingent Workers, and Manufacturing colleagues. 

• Assist with other MQA related tasks as needed. 

Here Is What You Need (Minimum Requirements) 

• Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience

• Fundamental knowledge of the principles and concepts of current Good Manufacturing Practices (cGMPs) used in the Pharmaceutical Industry. Knowledge of, and experience in a biopharmaceutical/pharmaceutical cGMP environment 

• Knowledge of electronic systems including Trackwise, PDOCs, SAP, gLIMS, AMPS, Microsoft Office. 

• Good judgment and correct decision making based on company procedures/standards, technical experience, and industry guidance / regulatory requirements 

• Strong critical thinking skills 

• Ability to work effectively within own team and interdepartmental teams 

• Proactive approach to problem-solving 

• Experience in the pharmaceutical industry and Quality administered systems 

• Sound knowledge of current Good Manufacturing Practices (part of GxP)  

• Effective written and oral communication skills 

Bonus Points If You Have (Preferred Requirements) 

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