Under general direction, serves as technical guide to cGMP operations in one or more core supply chain functions(s): receiving, storing, sampling, inspection, transferring, shipping materials. As well as LIMS sample logging, sample profile determination and material put away per standard operating procedures or guidelines.
We are one of the world’s leading biotechnology companies, with a focus on cardiovascular disease, oncology, bone health, neuroscience, nephrology and inflammation. And we put much of our success discovering and producing medicines and therapies down to our biology first approach.
In short, this is a place for innovation. Where ideas are not just welcome but celebrated. Where you will have a peer group of 20,000 motivational colleagues, not to mention the resources only a $20bn+ business can provide. This is your chance to create a positive impact on the world.
AML is Amgen’s largest multi-product manufacturing site and most of the combination products comprising Amgen’s portfolio move through this 1.7 million square foot biotechnology facility.
Specific responsibilities include but are not limited to:
Inspect raw materials, components, labels, labeled and packaged raw materials
Sample raw materials, labels, sanitary utilities
Generate/compile quality data and reports (e.g., LIMS, AMOS, lot track/trace, incidents)
Assist with document review Initiate incidents Room clearance inspection
General document coordination and compilation
Technical expert in the receipt, storage, dispensing, delivery, transfer, reconciliation, cycle counting, or shipment of materials per procedures and regulations
Identify operational issues and process improvement opportunities, determine solutions, own the effort to address
Participate in or lead multi-departmental, cross-functional multi-site projects of moderate scale
Able to train staff in all cGMP and operational functions
May monitor and audit work processes to ensure compliance
Serve as the group’s primary point of contact to internal and external customers, for complex operational issue, includes investigating and resolving issues
Assist others in preparation for regulatory inspections and audits
Participate in regulatory inspections and audits
Associate Degree and 4 years experience in Supply Chain
SAP and eBR knowledge and experience
2+years of Incoming inspection experience
Intermediate mathematical skills
Basic understanding of cGMPs
Clear, concise writing skills
Basic problem solving skills
Ability to interact constructively with peers
Ability to work as a teammate and/or independently
Ability to evaluate documentation and operations according to company procedures
Basic word processing, presentation and spreadsheet application skills
Demonstrate the ability to prioritize and meet deadlines
Good communication skills (both written and verbal)
Independently understand, follow and implement basic instructions
Demonstrate the Amgen Values
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.
Amgen focuses on areas of high unmet medical need and uses 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 you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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.