QA Associate
About The Position
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes.
Requirements
- Bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience.
- Experience in pharmaceutical industry
- Sound knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards.
- Ability to work in a team environment within own team and interdepartmental teams.
- Excellent communication and interpersonal skills
- Proactive approach and strong critical thinking skills.
- Effective written and oral communication skills
- Experience with Digital Applications /Solutions (Co-Pilot, AI applications, eBR, etc)
Nice To Haves
- Experience at a manufacturing site
- Experience of writing and managing deviations
- Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management is preferred
Responsibilities
- Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
- Review and approve various Good Manufacturing Practices also cGMP records (primarily batch records for Drug substance and Drug Product) and investigations.
- Review/Approve Standard Operating Procedures (SOPs) revisions and Validation Documentation (Periodic Reviews)
- Ensure that all documents for batch release are reviewed for completeness and accuracy.
- Make Quality decision to resolve moderately complex issues with assistance from management/Sr. Staff
- Seek out and assess internal and external compliance with applicable regulations.
- Support the site relative to a constant state of inspection readiness. Participate in audits relative to this role as needed.
- Recognize when an issue is beyond your sphere of influence and escalate immediately.
- Participate in Limited Duration Teams, Continuous Improvement (CI) projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate.
- Assist and support the manufacturing staff in detecting and solving compliance errors in real time during manufacturing operations.
- Help to define appropriate action plans for improvement and follow-up and communicate action closures.
- May participate in the release of raw materials, as needed.
- Procedural Administration/Active Library Support as needed
Benefits
- 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
- health benefits to include medical, prescription drug, dental and vision coverage
- Relocation assistance may be available based on business needs and/or eligibility.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
