Associate Quality Control I

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 - Bioanalytics

What you will do

Let’s do this. Let’s change the world.  In this vital role you will complete and review analytical testing in our cGMP laboratory. The role will be on-site based out of Amgen Rhode Island and will work under the mentorship of the front-line manager. The Bioanalytics team provides analytical expertise in testing the following: in-process, release and stability samples. The laboratory employs a variety of test methodologies that use sophisticated equipment including: HPLC/UPLC, capillary electrophoresis and general chemistry methodologies such as: Appearance, Color, Clarity, pH, Osmolality, Polysorbate, Protein Concentration, and Sub-Visible Particle testing.

Responsibilities include the following:

• Follow safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements

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

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

• Operate laboratory equipment and instrumentation

• Performs review and approval of assays, documents and records

• Supports Continual Improvement initiatives

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

• Participate in laboratory investigations

• Perform general laboratory housekeeping activities

• Completes required assigned training to permit carry through of required tasks

• Performs additional duties as specified by management

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 diploma/GED and 2 years of Quality experience OR

• Associate's degree and 6 months of Quality experience OR

• Bachelor's Degree

Preferred Qualifications

• 1-2 years’ experience in HPLC/UPLC, capillary electrophoresis and general chemistry methodologies such as: Appearance, Color, Clarity, pH, Osmolality, Polysorbate, Protein Concentration, and Sub-Visible Particle testing

• Demonstrated experience in laboratory investigations, method 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 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 towar