Sr Associate QA

SUMMARY

The Sr Associate QA role will support operations at the AML Inspection and Packaging Facility in a Non Standard Shifts Operations. The manufacturing operations require a seven (7) days a week coverage. Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under general supervision. Several positions available

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Prepare micro. certificates, ALN, QDS
• Perform Quality Oversight of Operations
• Sampling of product
• Compliance review of batch record elements (e.g., MPs, MSRs) and identification of discrepancies
• Participate in internal plant audits
• Work with operations to resolve basic compliance discrepancies
• Assist in Investigations
• May perform work of Associate QA

BASIC EDUCATION & EXPERIENCE

Master's degree

or

Bachelor's degree & 2 years of Quality experience in pharmaceutical, medical device or biotechnology industry

PREFERRED QUALIFICATION

• Educational background in Life Sciences or Engineering
• Basic statistical mathematical skills
• Basic knowledge of process and facility equipment
• GMP knowledge with ability to interpret and apply in routine cases
• Technical writing capability
• Demonstrated skill in problem solving and providing solutions
• Ability to interface effectively with various levels
• Basic understanding of analytical methods used in support of facility process monitoring
• Self-motivated
• Ability to work as a team player and/or independently
• Ability to evaluate documentation/ operations according to company guidelines
• Intermediate word processing, database, presentation and spreadsheet application skills
• Skill in prioritizing and meeting deadlines
• Good communication and presentation skills (both written and verbal)
• Independently understand, follow and implement instructions
• Ability to seek outside resources as needed
• Basic data trending
• Demonstrate the Amgen Values

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

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.

.