Sr. Associate, MQA (2nd Shift)

Use Your Power for Purpose
Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based 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.
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. 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.
In this role, you will:

• 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.
• 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.

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

• Role requires ability to gown into the manufacturing areas, standing work for several hours continuously.

Non-Standard work schedule, travel or environment requirements

• Second shift: 3PM-12AM

Other job details

• Last day to apply: April 25th, 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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