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 crossfunctionally 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 oncall 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 nonconformances deviations and other issues from the manufacturing floor including support for activities such as review of inprocess records AQL aseptic observations compliance walkthroughs smoke studies media fills alarms evaluation etc.

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

• Work crossfunctionally 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 crossdepartmental/crosssite meetings. Aid in resolving and provide guidance/pathforward.

• Independently makes decisions with minimal assistance from QA management.

• Support site regulatory inspections.

• Facilitate internal & external meetings and provide training/presentations/updates/reportout 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 Associates 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 problemsolving

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

Physical / Mental requirements

• Effective written and verbal communication skills coupled with interpersonal skills and the ability to establish relationships within the company.

• 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.

• Ability to positively receive feedback from management and colleagues.

• Takes accountability for actions and personal development.

• Ability to organize work tasks and adhere to assigned work to meet deadlines and departmental goals.

Other job details

• Last day to apply: May 2nd 2025

• No relocation support available

• Employee Referral Bonus eligible

• Work Location Assignment:On Premise

The annual base salary for this position ranges from $80300.00 to $133900.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 10.0 of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution paid vacation holiday and personal days paid caregiver/parental and medical leave and health benefits to include medical prescription drug dental and vision coverage. Learn more at Pfizer Candidate Site U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Quality Assurance and Control

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