Sr Associate QA I - PQA
Amgen
August 25, 2026
On-site
Holly Springs, NC
Operations
SR ASSOCIATE QA I – PQA
Responsibilities:
- Work with plant manufacturing/support groups for ongoing bulk drug substance manufacturing and new product introduction (development, clinical, commercial).
- Provide real-time decision making to ensure adherence to GMP quality requirements.
- Coach, guide, and direct manufacturing events, deviations, quality systems, and compliance.
- Support ANC facility commissioning/qualification and manufacturing Analytical Equipment Qualification and Validation; review/approve documents per project timelines.
- Provide quality oversight for new product introduction (facilities, utilities, equipment, systems, process) aligned with Amgen Quality Systems.
- Provide on-going quality oversight to ensure products are manufactured, tested, stored, and distributed per cGMP, GDP, and applicable regulations.
- Ensure facilities/equipment/materials/processes/procedures comply with relevant regulations and Amgen requirements.
- Drive closure/completion of cGMP processes/procedures/documents/records (deviations, investigations, CAPA, change control, validations).
- Ensure production/testing records are complete/accurate and documented per GDP and cGMP.
- Oversee and guide on-the-floor analytical testing.
- Assess changes impacting product quality; investigate/document deviations.
- Alert senior management to quality/compliance/supply/safety risks.
- Provide project management support; lead timely task achievement and system implementation strategy.
- Identify/implement continuous improvement opportunities.
- Support/represent PQA during audits/inspections; may interact with regulatory agencies.
Qualifications:
Basic:
- High school/GED + 4 yrs quality/manufacturing/regulated environment OR Associate’s + 2 yrs OR Bachelor’s + 6 months OR Master’s.
Preferred:
- Strong cGMP and GDP behaviors; biotech/pharma plant start-up experience.
- Knowledge/process experience in cGMP or highly regulated environments.
- Technical understanding of upstream and/or downstream biotech manufacturing.
- Microsoft Office; experience with electronic systems (EBR/MES, Delta V, Electronic Quality Systems).
- Demonstrated experience with deviations records; supporting GMP testing laboratories.
- Strong organizational, time-management, written/oral communication.
- Ability to work independently and as a team.
Application instructions:
- Apply now via careers.amgen.com.
- No application deadline; applications continue until a sufficient number are received or a candidate is selected.
Responsibilities:
- Work with plant manufacturing/support groups for ongoing bulk drug substance manufacturing and new product introduction (development, clinical, commercial).
- Provide real-time decision making to ensure adherence to GMP quality requirements.
- Coach, guide, and direct manufacturing events, deviations, quality systems, and compliance.
- Support ANC facility commissioning/qualification and manufacturing Analytical Equipment Qualification and Validation; review/approve documents per project timelines.
- Provide quality oversight for new product introduction (facilities, utilities, equipment, systems, process) aligned with Amgen Quality Systems.
- Provide on-going quality oversight to ensure products are manufactured, tested, stored, and distributed per cGMP, GDP, and applicable regulations.
- Ensure facilities/equipment/materials/processes/procedures comply with relevant regulations and Amgen requirements.
- Drive closure/completion of cGMP processes/procedures/documents/records (deviations, investigations, CAPA, change control, validations).
- Ensure production/testing records are complete/accurate and documented per GDP and cGMP.
- Oversee and guide on-the-floor analytical testing.
- Assess changes impacting product quality; investigate/document deviations.
- Alert senior management to quality/compliance/supply/safety risks.
- Provide project management support; lead timely task achievement and system implementation strategy.
- Identify/implement continuous improvement opportunities.
- Support/represent PQA during audits/inspections; may interact with regulatory agencies.
Qualifications:
Basic:
- High school/GED + 4 yrs quality/manufacturing/regulated environment OR Associate’s + 2 yrs OR Bachelor’s + 6 months OR Master’s.
Preferred:
- Strong cGMP and GDP behaviors; biotech/pharma plant start-up experience.
- Knowledge/process experience in cGMP or highly regulated environments.
- Technical understanding of upstream and/or downstream biotech manufacturing.
- Microsoft Office; experience with electronic systems (EBR/MES, Delta V, Electronic Quality Systems).
- Demonstrated experience with deviations records; supporting GMP testing laboratories.
- Strong organizational, time-management, written/oral communication.
- Ability to work independently and as a team.
Application instructions:
- Apply now via careers.amgen.com.
- No application deadline; applications continue until a sufficient number are received or a candidate is selected.