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 Product 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 Analytical Result Assessments/Deviations and provide Product Quality support during inspections and regulatory inquiries.
- Technical expertise for execution analytical tests methods
- Assist with the management of Reference Standards
- Provide Quality support for both internal and external method transfers and method validations
- Subject Matter Expert for analytical methods (i.e.Bioassay, Immunoassay, Chromatography, General, and/or Microbiology platform testing)
- 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 Forums
- Provides site support/representation for the Technical Excellence Teams
- Support external functional areas with QC LIMS Spotfire Reports.
- Doctorate degree
- Masters degree and 3 years of Quality experience
- Bachelors degree and 5 years of Quality experience
- Associates degree and 10 years of Quality experience
- High school diploma / GED and 12 years of Quality experience
- Degree in Life Sciences, Biochemistry, or related technical field.
- Experience executing analytical test methods in Bioassay and/or Immunoassay Testing
- Experience managing Reference Standards and critical reagents
- 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 deviations.
- 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
Join UsIf 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.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.