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Quality Assurance Senior Associate, Drug Substance Plant

2 months ago

Thousand Oaks, United States Amgen Full time

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.

Senior Associate Quality Assurance

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.

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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

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

  • Master's

Preferred Qualifications:

  • 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

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

  • 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, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.