Quality Assurance Senior Associate, Drug Substance Plant

Role Summary

Provide quality oversight for Drug Substance manufacturing facilities at Amgen Thousand Oaks, operating within a shift system. Under general supervision, you will support and ensure compliance for Manufacturing, Facilities, and Engineering staff in their processes, procedures, and use of quality systems. You will engage directly with a diverse range of partners, establishing effective working relationships with production operators, line leads, shift supervisors, warehouse staff, facilities, maintenance, and engineering teams. This role requires your local presence at the Amgen Thousand Oaks site. The schedule is Sunday-Wednesday with rotations across Day, Swing, and Night shifts.

Responsibilities

• Provide daily guidance and support to Production staff on compliance with Standard Operating Procedures (SOPs) and Work Instructions.
• Maintain a strong presence in Drug Substance (DS) areas to oversee GMP operations and quality systems.
• Serve as the first point of contact for quality-related production queries during DS operations.
• Lead, mentor, and coach Operations and support personnel on quality matters, fostering a strong Quality culture at the site.
• Review and approve batch production records and other GMP documentation to support daily operations.
• Compile and review batch records for manufactured lots in preparation for batch disposition.
• Own, review, and approve controlled documents, including SOPs, Work Instructions, and Forms.
• Collaborate effectively within a team matrix environment.
• Work across a three shift rotation including night shift.

Qualifications

• Required: Basic Qualifications: High school/GED + 4 years quality assurance work experience OR Associate’s + 2 years quality assurance work experience OR Bachelor’s + 6 months quality assurance work experience OR Master’s
• Preferred: Quality and manufacturing experience in biotech or pharmaceutical industry
• Preferred: Bachelor’s Degree in a Science Field
• Preferred: Ability to successfully manage workload to timelines
• Preferred: Familiarity with basic project management tools
• Preferred: Demonstrated ability to consistently deliver on-time, and high-quality results
• Preferred: Ability to operate in a matrixed or team environment