Specialist Quality Control

The Specialist Quality Control will be responsible for performing technical support activities at the Amgen Rhode Island site. The Technical Services group plays a critical role supporting New Production Introduction (NPI) and Technology Transfer (TT) for the site. Support activities including analytical testing, method transfer, method validation, data management and trend analysis, troubleshooting assay / instrument performance issues, and investigation of unexpected test results.

The Quality Control Specialist provides support to core laboratory operations, including:

• Management of multiple product activities as assigned, including participation in ARA and Deviations and provide Product Quality support during inspections and regulatory inquiries.
• Technical expertise for execution analytical tests methods: HPLC, UPLC, GC.
• Provide Quality support for both internal and external method transfers and method validations
• Subject Matter Expert for Polysorbate, Glycan map, Peptide map, Titer, and ICP-MS method owner
• Method Revision Change Control Owner
• Supports troubleshooting, problem solving, and investigations as platform technical specialist
• Provides technical support to Amgen Rhode Island Attribute Sciences, Quality Control, and Manufacturing Chromatography Forum
• Provides site support/representation for General and Chromatography Technical Excellence Teams
• Support external functional areas with QC LIMS Spotfire Reports.

Basic Qualifications:

• Doctorate degree
• OR
• Master's degree and 3 years of Quality experience
• OR
• Bachelor's degree and 5 years of Quality experience
• OR
• Associate's degree and 10 years of Quality experience
• OR
• High school diploma / GED and 12 years of Quality experience

Preferred Qualifications

• Degree in Life Sciences, Biochemistry, or related technical field.
• Experience executing analytical test methods in one or more of the following areas: Raw Material Testing, Chromatography (HPLC/GC), Testing per Pharmacopeia (USP/EP/JP)
• Previous experience with transfer and/or validation of analytical methods.
• Experience with operation, maintenance, and troubleshooting of laboratory equipment and instrumentation related to analytical testing.
• Statistical knowledge, ability to trend data and apply corrective actions to interpretations of complex data sets.
• Demonstrated technical writing skills within a highly regulated environment, including documentation of investigational testing and problem-solving techniques related to nonconformances.
• Exposure to Operational Excellence initiatives including Lean Manufacturing and 5S.
• Previous experience in a regulated GMP environment. Exposure to regulatory agency inspections (or participation in internal audits).
• Experience with analytical laboratory testing to support technical discussions and troubleshooting.
• Ability to work independently and deliver right first-time results
• Data integrity focus

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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, or disability status.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.