Use Your Power for Purpose

The Manufacturing Quality Operations Senior Associate provides Quality Assurance (QA) support to all modalities manufactured on site including clinical, commercial, and contract manufacturing operations providing QA Operations 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, batch record review, line clearance approvals, alarms evaluation, on the floor triage, and on the floor real time batch record review. The Senior Associate will work cross-functionally with 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 and provides on-call, after hours and weekend support to ensure no interruptions of 24/7 operations. The work schedule is based on the shift posted in requisition and could require limited travel but no more than 5%.  

What You Will Achieve

The Manufacturing Quality Operations Senior Associate support includes:

• Documentation review, facility walkthrough, remediation/escalation of non-conformances, deviations, and other issues from the manufacturing floor including support for activities such as review of in-process records, AQL, aseptic observations, compliance walkthroughs, smoke studies, media fills, alarms evaluation, 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), complete impact assessment, and identify Corrective/Preventive Action (CAPA).

• Represent QA in cross-departmental/cross-site meetings. Aid in resolving and provide guidance/path-forward.

• Independently makes decisions with minimal assistance from QA management.

• Support site regulatory inspections.

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

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

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

• Provide guidance/coaching and training to less experienced QA and Manufacturing colleagues.

• Assist with other tasks as needed such as: Internal Audits/Assessments, Gap Analysis, Regulatory Inspection Readiness.

Here Is What You Need (Minimum Requirements)

• BA/BS degree in Microbiology, Chemistry, Biological Sciences, Bioengineering (preferred) with 2+ years of experience OR MBA/MS degree in Microbiology, Chemistry, Biological Sciences, Bioengineering (preferred) with any years of relevant experience OR Associate’s degree in Microbiology, Chemistry, Biological Sciences, Bioengineering (preferred) with 6+ years of experience OR High school diploma (or equivalent) with 8+ years of 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, Documentum/PDOCs, SAP, gLIMS, 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

• Good working knowledge of Microsoft Excel and Word

• Proactive approach to problem-solving

Bonus Points If You Have (Preferred Requirements)

• Experience in quality administered systems

• Strong organizational skills and attention to detail

• Experience with regulatory compliance and documentation

• Ability to mentor and review the work of other colleagues