Career Category Quality Job Description Are you looking for a meaningful new opportunity to test and growth your technical skills? We have an immediate need for Sr Associate QA's to join AMLs Quality Organization. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.The Role 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 Amgens Quality Assurance program under general supervision. Several positions available. Specific responsibilities include but are not limited to: - 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 Masters degreeor Bachelors degree and 2 years of Quality experience in pharmaceutical, medical device or biotechnology industryPreferred qualifications - Educational background in Life Sciences or Engineering - Basic statistical mathematical skills - Basic knowledge of process and facility equipment - Knowledge in systems like Trackwise, Electronic Batch Record(EBR), SAP, LIMS - GMP knowledge with ability to interpret and apply in routine cases - Technical writing capability - Proven skills in problem solving and providing solutions - Ability to interface optimally 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 - Demonstrate the Amgen Values The benefits Our broad approach is one of the reasons why we are regularly recognized as a Best Place To Work. We offer an outstanding benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program and on-site child care and fitness facilities you will find us passionate about your well-being too. 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 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 demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds 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. .
