QA Associate
Pfizer
August 21, 2026
On-site
Andover, MA
Operations
What You Will Achieve (In this role, you will):
- Contribute to complex projects; manage your time to meet targets and plan work activities within a team.
- Review and approve cGMP/Good Manufacturing Practices records (primarily batch records for Drug substance and Drug Product) and investigations.
- Review/approve SOP revisions and Validation Documentation (Periodic Reviews).
- Ensure batch release documents are complete and accurate.
- Resolve moderately complex quality issues with assistance from management/senior staff.
- Assess internal/external compliance with applicable regulations.
- Support inspection readiness; participate in audits as needed.
- Recognize issues beyond your scope and escalate immediately.
- Participate in CI, CAPA effectiveness, and limited-duration teams.
- Assist manufacturing staff in detecting/solving compliance errors in real time.
- Define improvement action plans, follow up, and communicate closures.
- May participate in releasing raw materials; provide procedural administration/active library support as needed.
Minimum Requirements:
- Bachelor’s degree (any years) or Associate’s degree with 4 years relevant experience, or high school diploma (or equivalent) with 6 years relevant experience.
- Experience in the pharmaceutical industry.
- Sound knowledge of current cGMP and applicable GxP regulations/standards.
- Teamwork ability (own and cross-functional teams).
- Excellent communication/interpersonal skills; effective written and oral communication.
- Proactive, strong critical thinking.
- Experience with digital applications/solutions (e.g., Co-Pilot, AI apps, eBR).
Preferred Requirements:
- Experience at a manufacturing site.
- Experience writing/managing deviations.
- Preferred: production batch record review, ERP, non-conformance investigations, root cause analysis, change control management.
Application:
- Last day to apply: August 28, 2026
- Work location: On premise
- Contribute to complex projects; manage your time to meet targets and plan work activities within a team.
- Review and approve cGMP/Good Manufacturing Practices records (primarily batch records for Drug substance and Drug Product) and investigations.
- Review/approve SOP revisions and Validation Documentation (Periodic Reviews).
- Ensure batch release documents are complete and accurate.
- Resolve moderately complex quality issues with assistance from management/senior staff.
- Assess internal/external compliance with applicable regulations.
- Support inspection readiness; participate in audits as needed.
- Recognize issues beyond your scope and escalate immediately.
- Participate in CI, CAPA effectiveness, and limited-duration teams.
- Assist manufacturing staff in detecting/solving compliance errors in real time.
- Define improvement action plans, follow up, and communicate closures.
- May participate in releasing raw materials; provide procedural administration/active library support as needed.
Minimum Requirements:
- Bachelor’s degree (any years) or Associate’s degree with 4 years relevant experience, or high school diploma (or equivalent) with 6 years relevant experience.
- Experience in the pharmaceutical industry.
- Sound knowledge of current cGMP and applicable GxP regulations/standards.
- Teamwork ability (own and cross-functional teams).
- Excellent communication/interpersonal skills; effective written and oral communication.
- Proactive, strong critical thinking.
- Experience with digital applications/solutions (e.g., Co-Pilot, AI apps, eBR).
Preferred Requirements:
- Experience at a manufacturing site.
- Experience writing/managing deviations.
- Preferred: production batch record review, ERP, non-conformance investigations, root cause analysis, change control management.
Application:
- Last day to apply: August 28, 2026
- Work location: On premise