Quality Assurance Senior Associate, Drug Substance Plant

Amgen • Thousand Oaks, CA

7h • Onsite

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Quality Assurance Senior Associate, Drug Substance Plant What you will do Let’s do this! Let’s change the world! In this role as Senior Associate QA, you will be responsible for providing quality oversight to Drug Substance manufacturing facilities at Amgen Thousand Oaks, working 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 (ATO) site.

Requirements

• 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

Nice To Haves

• Quality and manufacturing experience in biotech or pharmaceutical industry
• Bachelor’s Degree in a Science Field
• Ability to successfully manage workload to timelines
• Familiarity with basic project management tools
• Demonstrated ability to consistently deliver on-time, and high-quality results
• Ability to operate in a matrixed or team environment

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.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees