Quality Control Associate

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.

Quality Control Associate - Bio analytics

What you will do

Let’s do this! Let’s change the world!

In this vital role the Associate in Quality Control at Amgen contributes to maintaining the quality of products and manufacturing processes. They perform QC testing, analyze results, document findings, and work with the production team to address any quality issues.

Responsibilities include the following:

• Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks

• Operate and maintain specialized laboratory equipment and instrumentation

• Participate in laboratory investigations and audits as necessary

• At all times, follow safety guidelines, cGMPs and other applicable regulatory requirements

• Ensure that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations

• Perform review of procedures, assays, documents and records, including but not limited to Nonconformance records and CAPAs Support Continuous Improvement initiatives, programs and projects

• Alert management of quality, compliance, supply and safety risks

• Support internal/external audits and inspections

• Complete assigned training to permit delivery of tasks

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek thrives in a fast-paced environment and possesses these qualifications.

Basic Qualifications:

• High school/GED + 2 years applicable Quality experience work or military experience OR

• Associate’s + 6 months applicable Quality experience work or military experience OR

• Bachelor’s Degree

Preferred Qualifications:

• 1 + years’ experience in Capillary Electrophoresis (CE), HPLC/UPLC, preferably protein chemistry, and other compendial methods such as UV, pH, Osmolality, Polysorbate testing, Appearance, Color and Clarity.

• Demonstrated experience in investigations, validation, audits, QC processes

• Proven ability to interpret scientific data

• Self-motivated, strong organizational skills and ability to manage multiple tasks at one time with minimal direction

• Strong communication skills (both written and oral), facilitation and presentation skills GMP/GDP experience

What you can expect from 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 p