Sr. Associate Quality Assurance-MQA

Pfizer

72d • $80,300 - $133,900

About The Position

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, 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.

Requirements

• BA/BS degree in Microbiology, Chemistry, Biological Sciences, Bioengineering (preferred) with 2+ years of experience OR MBA/MS degree in the same fields with any years of relevant experience OR Associate’s degree with 6+ years of experience OR High school diploma with 8+ years of experience.
• Fundamental knowledge of current Good Manufacturing Practices (cGMPs).
• Experience in a biopharmaceutical/pharmaceutical cGMP environment.
• Knowledge of electronic systems including Trackwise, Documentum/PDOCs, SAP, gLIMS, Microsoft Office.
• Good judgment and decision-making based on company procedures and 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.

Nice To Haves

• 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.

Responsibilities

• Provide Quality Assurance (QA) support to all modalities manufactured on site.
• Ensure adherence to regulatory expectations, safety, and GxP.
• Conduct Aseptic Observations and batch record reviews.
• Approve line clearances and evaluate alarms.
• Perform on the floor triage and real-time batch record reviews.
• Work cross-functionally with manufacturing and support groups.
• Investigate manufacturing events and support regulatory inspections.
• Provide on-call, after hours, and weekend support.

Benefits

• 401(k) plan with Pfizer Matching Contributions.
• Paid vacation, holiday, and personal days.
• Paid caregiver/parental and medical leave.
• Health benefits including medical, prescription drug, dental, and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees