MQA Associate (2nd Shift)
MQA Associate (2nd Shift)
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Job Description
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 Assurance Associate (MQA) 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 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 MQA Associate support includes documentation review facility walkthrough support for activities such as review of in-process records aseptic observations compliance walkthroughs 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)
Bachelors degree with any years of experience or an Associates degree with 4 years of relevant 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
Second shift: Monday Friday 3PM-12AM
No relocation available
Last Day to Apply: July 30th 2025
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 providers 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.
Required Experience:
IC
Employment Type
Full-Time
