Quality Assurance Senior Associate

Use Your Power for Purpose

Every day Pfizers unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and riskbased 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.

This position will perform batch disposition for clinical and commercial materials. The role ensures adherence to regulatory expectations and GxP (i.e. Current Good Manufacturing and Documentation Practices). Duties include but are not limited to generation of COA/COC and product disposition. The Senior Quality Assurance Associate will evaluate documentation and quality systems to ensure all items have been appropriately addressed prior to batch disposition.

What You Will Achieve

In this role you will:

• Perform final product disposition for commercial and clinical products using computer software applications including but not limited to: gLIMS and SAP
• Assess manufacturing operations/documentation and quality systems 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 deviation 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.
• 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.
• Review/approve new/existing documentation in Documentum/ PDOCS to ensure proposed critical changes to procedures and/or processes are completed/documented appropriately.
• Assist with other tasks as needed such as: Internal Audits/Assessments Regulatory Agency Response Coordination Gap Analysis Regulatory Inspection Readiness.
• Provide timely responses for board of health queries.

Here Is What You Need (Minimum Requirements)

• High school diploma (or equivalent) with 8 years of experience or associates degree with 6 years of experience or BA/BS with 2 years of experience or MBA/MS with 0 years of relevant experience
• Ability to work effectively within own team and interdepartmental teams
• Fundamental knowledge of the principles and concepts of current Good Manufacturing Practices (cGMPs) used in the Pharmaceutical Industry.
• Collaboration skills and the ability to independently engage with a wide range of colleagues customers and management to gather the input and background knowledge needed to complete assignments.
• Strong attention to detail.
• Ability to organize work tasks and adhere to assigned work to meet deadlines site metrics and departmental goals.

Bonus Points If You Have (Preferred Requirements)

• Knowledge of electronic systems including Trackwise Documentum/PDOCs SAP gLIMS and Microsoft Office.
• Experience with regulatory compliance and documentation

PHYSICAL/MENTAL REQUIREMENTS

• Ability to work in a fastpaced dynamic environment

• Able to manage different priorities

• Able to sit and review documentation for long periods of time

NONSTANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

• Regular Business hours or shift schedule

• May require occasionally off shift support to support supply demand

OTHER JOB DETAILS

Last Date to Apply for Job: 4/22/25

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 (uscandidates.mypfizerbenefits). 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