Aseptic QA Coach - Real-Time Manufacturing Oversight

Amgen SA; Thousand Oaks (CA); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

Employee benefits package

Retirement and savings plan

Stock-based incentives

Award-winning time-off plans

Job summary

Amgen seeks a Senior Associate Quality Assurance / Aseptic Coach to support the Drug Product manufacturing floor in a 24/7 aseptic filling facility. The role provides real-time QA oversight, ensures compliance with GMP, and reviews electronic batch records and SOPs.

Ideal candidates will have GMP experience at different education levels and demonstrate leadership, strong documentation skills, and the ability to work both independently and as part of a team across rotating day/night shifts.

Qualifications

• High school/GED + 4 years of GMP experience OR
• Associate’s + 2 years of GMP experience OR
• Bachelor’s + 6 months of GMP experience
• Master’s (not specified)

Responsibilities

• Purposeful presence on the manufacturing floor with gowning
• Real-time aseptic oversight and coaching of filling activities
• Support real-time troubleshooting and triage with quality
• Review/approve SOPs, documents, and deviations
• Electronic batch record review and MES documentation revisions
• Support second/third shift rotations to meet production
• Ensure compliance with GMP and regulatory requirements

Skills

GMP experience

Quality systems

Documentation practices

Leadership attributes

Team player / independent

Education

Bachelor’s in Biochemistry/ Biology/ Chemistry

Job description

Amgen seeks a Senior Associate Quality Assurance / Aseptic Coach to support the Drug Product manufacturing floor in a 24/7 aseptic filling facility. The role provides real-time QA oversight, ensures compliance with GMP, and reviews electronic batch records and SOPs.

Ideal candidates will have GMP experience at different education levels and demonstrate leadership, strong documentation skills, and the ability to work both independently and as part of a team across rotating day/night shifts.