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)

• Bachelor's degree in microbiology, chemistry, biological sciences, bioengineering (preferred) with 0 years of experience, OR Associate’s 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.