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

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 $80,300.00 to $133,900.00. In addition, this position is eligible for participation in Pfizer’s 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 life’s 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.com). 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.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.  These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Pfizer is an E-Verify employer.  This position requires permanent work authorization in the United States.

Quality Assurance and Control

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