Sr Associate QA I
Amgen
3 days ago
On-site
Holly Springs, NC
Operations
SR ASSOCIATE QUALITY ASSURANCE (PQA) – NIGHT SHIFT
What You Will Do
- Sr. Associate Plant Quality Assurance (PQA) on-the-floor role supporting bulk drug substance manufacturing and new product introduction across development, clinical, and commercial operations; facilitates real-time decisions to ensure adherence to GMP.
- Provide coaching/guidance for manufacturing events, deviations, quality systems, and compliance.
Responsibilities
- Quality oversight of new product introduction (facilities, utilities, equipment, systems/process), incl. commissioning/qualification/validation and new documentation.
- Ensure products are manufactured, tested, stored, and distributed per cGMP, GDP, and applicable regulations.
- Ensure compliance of facilities/equipment/materials/organization/processes/procedures with cGMP/GDP, safety, and other controls.
- Drive closure/review/approval of cGMP documents/records incl. deviations, investigations, CAPA, change control, and validations.
- Ensure production/testing records are complete, accurate, and documented per GDP/cGMP.
- Oversee on-the-floor analytical testing; assess quality-impacting changes.
- Ensure deviations are investigated/documented; alert senior management to quality/compliance/supply/safety risks.
- Provide project management support; identify/implement continuous improvement.
- Support PQA in audits/inspections; may interact with regulatory agencies.
Qualifications
Basic:
- High school/GED +4 years; or Associate’s +2 years; or Bachelor’s +6 months in QA, manufacturing, and/or other regulated environment work.
Preferred:
- Strong cGMP/GDP; biotech/pharma plant start-up; regulated environment experience; upstream/downstream understanding; Microsoft Office; EBR/MES/Delta V/electronic quality systems; deviations records; GMP testing lab experience; strong organization; written/oral communication; team and independent work.
Benefits (if eligible)
- Health/welfare plans, retirement & savings, life/disability, flexible spending, bonus/incentives, stock-based long-term incentives, time-off plans.
Application Instructions
- Apply via careers.amgen.com; no application deadline (accepted until sufficient applications/candidate selected). Sponsorship not guaranteed.
What You Will Do
- Sr. Associate Plant Quality Assurance (PQA) on-the-floor role supporting bulk drug substance manufacturing and new product introduction across development, clinical, and commercial operations; facilitates real-time decisions to ensure adherence to GMP.
- Provide coaching/guidance for manufacturing events, deviations, quality systems, and compliance.
Responsibilities
- Quality oversight of new product introduction (facilities, utilities, equipment, systems/process), incl. commissioning/qualification/validation and new documentation.
- Ensure products are manufactured, tested, stored, and distributed per cGMP, GDP, and applicable regulations.
- Ensure compliance of facilities/equipment/materials/organization/processes/procedures with cGMP/GDP, safety, and other controls.
- Drive closure/review/approval of cGMP documents/records incl. deviations, investigations, CAPA, change control, and validations.
- Ensure production/testing records are complete, accurate, and documented per GDP/cGMP.
- Oversee on-the-floor analytical testing; assess quality-impacting changes.
- Ensure deviations are investigated/documented; alert senior management to quality/compliance/supply/safety risks.
- Provide project management support; identify/implement continuous improvement.
- Support PQA in audits/inspections; may interact with regulatory agencies.
Qualifications
Basic:
- High school/GED +4 years; or Associate’s +2 years; or Bachelor’s +6 months in QA, manufacturing, and/or other regulated environment work.
Preferred:
- Strong cGMP/GDP; biotech/pharma plant start-up; regulated environment experience; upstream/downstream understanding; Microsoft Office; EBR/MES/Delta V/electronic quality systems; deviations records; GMP testing lab experience; strong organization; written/oral communication; team and independent work.
Benefits (if eligible)
- Health/welfare plans, retirement & savings, life/disability, flexible spending, bonus/incentives, stock-based long-term incentives, time-off plans.
Application Instructions
- Apply via careers.amgen.com; no application deadline (accepted until sufficient applications/candidate selected). Sponsorship not guaranteed.