Senior Associate Quality Assurance / Aseptic Coach
Amgen
August 07, 2026
On-site
Thousand Oaks, CA
Operations
Senior Associate Quality Assurance / Aseptic Coach
What You Will Do
- Provide daily oversight of Drug Product manufacturing areas and ensure execution of processes, procedures, and quality systems aligns with regulatory requirements.
Duties include but are not limited to:
- Perform 100% Manual Visual Inspection support, ASP/AQL performance, and QA Oversight Assessments (Form/Fill Grade 8 Gowning).
- Provide real-time aseptic oversight and coaching of filling activities.
- Support real-time troubleshooting and triage with quality and aseptic compliance.
- Support quality-related decision making for non-routine interventions and documentation.
- Review electronic batch records.
- Review/approve GMP document (SOPs/FORMs) revisions.
- Review/approve electronic maintenance documentation work orders/job plans.
- Approve minor deviations.
- Review/approve electronic Batch Record (MES) documentation revisions.
- Support predominantly second/third shift work.
Additionally
- Flexible with shift work (including weekends) and gowning requirements for 24/7 Grade 8 clean room drug product filling.
- Shifts may vary from 8 to 12 hours (Days, Swings, Graves); rotations required.
Basic Qualifications
- High school/GED + 4 years of GMP experience OR Associate’s + 2 years OR Bachelor’s + 6 months OR Master’s.
Preferred Qualifications
- Bachelor’s in Biochemistry, Biology, Chemistry, or related science.
- Ability to perform GMP operations (SOP adherence, training maintenance, good documentation).
- Project management to completion with timeline success.
- Experience evaluating documentation/operations per company procedures.
- Experience with Quality Systems; strong organization and multitasking; written/verbal communication.
- Team player and independent; leadership and improvement initiative drive.
- Solid understanding/application of aseptic behaviors and principles.
Benefits (explicitly stated)
- Comprehensive employee benefits package (retirement/savings, medical/dental/vision, life/disability, flexible spending accounts).
- Discretionary annual bonus (or sales incentive for field sales).
- Stock-based long-term incentives.
- Award-winning time-off plans.
Application Instructions
- Apply at careers.amgen.com. No application deadline; applications accepted until a sufficient number are received or a candidate is selected.
What You Will Do
- Provide daily oversight of Drug Product manufacturing areas and ensure execution of processes, procedures, and quality systems aligns with regulatory requirements.
Duties include but are not limited to:
- Perform 100% Manual Visual Inspection support, ASP/AQL performance, and QA Oversight Assessments (Form/Fill Grade 8 Gowning).
- Provide real-time aseptic oversight and coaching of filling activities.
- Support real-time troubleshooting and triage with quality and aseptic compliance.
- Support quality-related decision making for non-routine interventions and documentation.
- Review electronic batch records.
- Review/approve GMP document (SOPs/FORMs) revisions.
- Review/approve electronic maintenance documentation work orders/job plans.
- Approve minor deviations.
- Review/approve electronic Batch Record (MES) documentation revisions.
- Support predominantly second/third shift work.
Additionally
- Flexible with shift work (including weekends) and gowning requirements for 24/7 Grade 8 clean room drug product filling.
- Shifts may vary from 8 to 12 hours (Days, Swings, Graves); rotations required.
Basic Qualifications
- High school/GED + 4 years of GMP experience OR Associate’s + 2 years OR Bachelor’s + 6 months OR Master’s.
Preferred Qualifications
- Bachelor’s in Biochemistry, Biology, Chemistry, or related science.
- Ability to perform GMP operations (SOP adherence, training maintenance, good documentation).
- Project management to completion with timeline success.
- Experience evaluating documentation/operations per company procedures.
- Experience with Quality Systems; strong organization and multitasking; written/verbal communication.
- Team player and independent; leadership and improvement initiative drive.
- Solid understanding/application of aseptic behaviors and principles.
Benefits (explicitly stated)
- Comprehensive employee benefits package (retirement/savings, medical/dental/vision, life/disability, flexible spending accounts).
- Discretionary annual bonus (or sales incentive for field sales).
- Stock-based long-term incentives.
- Award-winning time-off plans.
Application Instructions
- Apply at careers.amgen.com. No application deadline; applications accepted until a sufficient number are received or a candidate is selected.