Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

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.

• Support 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.
• Review/approve new/existing procedures (SOPs, MBRs, Job Aids, etc.) in Documentum/ PDOCS to ensure proposed critical changes to procedures and/or processes are completed/documented appropriately.
• Provide guidance/coaching to less experienced QA and Manufacturing colleagues.
• Assist with other tasks as needed such as: Internal Audits/Assessments, Gap Analysis, Regulatory Inspection Readiness.

• High School Diploma (or Equivalent) and 8 years of relevant experience; OR an Associate's Degree with 6 years of experience OR; a Bachelor's degree with at least 3 years of experience; OR a Master's degree with more than 1 year of experience.
• Experience in Quality Operations.
• Working knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
• Effective communication and interpersonal skills
• Familiar with Microsoft Office tools (Microsoft Excel and Word)

• Bachelor's or Master's degree in microbiology, chemistry, biological sciences or bioengineering.
• Relevant pharmaceutical experience, fundamental knowledge of the principles and concepts of current Good Manufacturing Practices (cGMPs).
• Collaboration skills and the ability to independently engage with a wide range of co-workers, customers, and management to gather the input and background knowledge needed to complete assignments.
• Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure
• Knowledge of electronic systems such as Trackwise, Documentum/PDOCs, SAP, gLIMS, Microsoft Office.

• Position requirements are typical for an office-lab based work environment
• Good judgment and correct decision making based on company procedures/standards, technical experience, and industry guidance / regulatory requirements.
• Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener.
• Strong attention to detail.
• Proactively identifies, takes remedial action, and/or seeks advice when a personal, project, or team goal/deliverable timeline is at risk.
• Takes accountability for actions and personal development.

• This position is a 12-hour shift (7:00AM - 7:00PM) in Sunday - Wednesday shift.
• Able to follow safe practices and aseptic gowning requirements

• Last day to Apply: December 27th, 2024
• Eligible for Relocation Assistance: NO
• Work Location Assignment: On Premise