Sr Associate QA - Drug Substance Plant

Career Category

Job Description

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 - Drug Substance Plant

What you will do

Let’s do this. Let’s change the world. This role supports Amgen’s Quality Assurance program providing daily oversight of Drug Substance manufacturing facilities at Amgen Thousand Oaks. Under general supervision, the role provides support and compliance oversight to MFG and F&E staff in the execution of their processes, procedures, and use of quality systems. Duties include electronic batch record review, paper and logbook record review, SOP and MP revision approval, work order approval, and quality approval of non-conformances and CAPAs. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The incumbent will also represent the Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications

Basic Qualifications:

• High school/GED + 4 years Quality work experience OR

• Associate’s + 2 years Quality work experience OR

• Bachelor’s + 6 months Quality work experience

• Master's

Preferred Qualifications:

• Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field.

• Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices.

• Experience managing projects through to completion meeting timelines

• Evaluating documentation and operations according to company procedures

• Capable of making decisions independently and determining when to elevate to management, as appropriate in an environment that balances business need, quality and compliance risk

• Experience working with Quality Systems

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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 and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline