Quality Assurance Associate

Use Your Power for Purpose

Every day Pfizers 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 Associate provides Quality Assurance (QA) support to all modalities manufactured on site including clinical commercial and contract manufacturing operations providing QA 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 line clearance approvals alarms evaluation on the floor triage and on the floor real-time batch record review. The Associate will work cross-functionally with MQA Sr. Associates 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.

In this role you will:

• The Manufacturing Quality Operations Associate support includes documentation review facility walkthrough support for activities such as review of in-process records AQL aseptic observations compliance walkthroughs smoke studies media fills alarms evaluation Product Changeovers 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) aid in the completion of impact assessment and identification of Corrective/Preventive Action (CAPA).

• Aid in resolving manufacturing events and provide opinion guidance/path-forward. Consults with MQA Sr Associates and/or MQA Manager to align on decisions.

• Support site regulatory inspections.

• Facilitate internal & external meetings and provide training/presentations/updates/report-out to QA and Manufacturing colleagues on a regular basis.

• Suggest Continuous Improvements (CI) initiatives to improve safety and processes and successfully utilize IMEX tools and the one best way philosophy.

• Perform paper/electronic compound batch record review/disposition using computer software applications including but not limited to: gLIMS SAP MES AMPS Batch Tracker.

• Provide guidance/coaching to less experienced QA Contingent Workers and Manufacturing colleagues.

• Assist with other MQA related tasks as needed.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelors degree with 0 years of experience; OR an associates degree with 4 years of experience; OR a 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 Industry. Knowledge of and experience in a biopharmaceutical/pharmaceutical cGMP environment

• Knowledge of electronic systems including Trackwise PDOCs SAP gLIMS AMPS 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

• Proactive approach to problem-solving

• Experience in the pharmaceutical industry and Quality administered systems

• Sound knowledge of current Good Manufacturing Practices (part of GxP)

• Effective written and oral communication skills

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

• Experience at a manufacturing site.

• Experience in production batch record review batch disposition investigation of non-conformance root cause analysis and change control management

• Strong problem-solving skills

• Ability to work independently and as part of a team

• Excellent time management and multitasking abilities

PHYSICAL/MENTAL REQUIREMENTS

Role requires ability to gown into manufacturing areas standing for several hours continuously.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Adhere to safe work practices and procedures such as aseptic gowning

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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