Use Your Power for Purpose

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 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 batch record review line clearance approvals alarms evaluation on the floor triage and on the floor real time batch record review. The MQA Associate will work cross-functionally with manufacturing and support groups to support resolution of manufacturing events 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.

What You Will Achieve

The Manufacturing Quality Operations 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 aseptic observations compliance walkthroughs 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).

Independently makes decisions with minimal assistance from QA management.

Support 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.

Here Is What You Need (Minimum Requirements)

• Bachelors degree in microbiology chemistry biological sciences bioengineering (preferred) with 0 years of experience OR Associates degree in microbiology chemistry biological sciences bioengineering (preferred) with 4 years of experience or 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 or Biopharma Industry.

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

• 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.

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

• Strong attention to detail.

• Takes accountability for actions and personal development.

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

Bonus Points If You Have (Preferred Requirements)

• Knowledge of electronic systems including Trackwise Documentum/PDOCs SAP gLIMS Microsoft Office.

• Ability to positively receive feedback from management and colleagues.

Other job details

• Last day to apply: July 3rd 2025

• No relocation support available

• Employee Referral Bonus eligible

• Work Location Assignment:On Premise

The annual base salary for this position ranges from $66500.00 to $110900.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 7.5% 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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