Associate Quality Control (Barrington)
Employment Type: Full-Time
Industry: Healthcare - Allied Health
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Amgen's Raw Material Centralized Testing Laboratory is seeking an associate laboratory analyst to execute and review analytical testing in our cGMP laboratory. The role will be based out of Amgen Rhode Island and will work under the guidance of the hiring manager. It is an administrative shift, Monday through Friday.
The Raw Material Centralized Testing team provides analytical expertise in testing raw materials to meet Amgen specifications and ensure a constant supply of raw materials for Amgen products. The laboratory employs a variety of test methodologies from basic wet chemistry identifications and titrations to complex instrumental analysis of a substance's critical parameters. The team provides these crucial services for the entire Amgen production network, to ensure only the highest quality raw materials are used to create products for our patients. Responsibilities
- Comply with 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 comply with 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 execution of required tasks
- Performs additional duties as specified by management
Associate's degree and 4 years of Quality or Operations experience
High school diploma / GED and 6 years of Quality or Operations experiencePreferred Qualifications
- Professional work experience in a fast-paced, flexible GxP laboratory
- Demonstrated experience with various laboratory practices
- Self-motivated, strong organizational skills and ability to manage multiple tasks at one time with supervision
- Strong communication skills (both written and oral), facilitation and presentation skills
- Demonstrated ability to be flexible and adaptable
- Knowledge of pharmacopoeial testing, USP (United States Pharmacopeia) and PhEUR (European Pharmacopeia).
- Experience with benchtop wet chemistry (color change/precipitation reactions, titrations etc.) or HPLC/GC (high-performance liquid chromatography/gas chromatography) experience
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.
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.
Associated topics: blood collection, lab, medical lab science, microbiology, mls, pathology, sample collection, surgical technologist, technician ii, toxicology
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