Amgen Sr. Associate QA in Juncos, Puerto Rico
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Sr. Associate QA – AML1
What you will do
Let’s do this. Let’s change the world. In this vital role you 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. We have multiple positions available.
Specific responsibilities include but are not limited to:
Responsible for providing Quality oversight to ensure that operations for clinical and licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and other applicable regulations
Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP, cGLP practices, and other applicable regulations
Actively engage in Continuous Improvement initiatives, programs and projects
Ensures that changes that could potentially impact product quality are assessed according to procedures
Ensures that deviations from established procedures are investigated and detailed per procedures
Ensures that production records and testing results are complete, accurate, and detailed according to written procedures, cGMP, and cGLP requirements
Participate in internal plant audits
Assist in Investigations
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. qualifications. The Sr. Associate QA professional we seek is an individual contributor with these qualifications:
Basic qualifications are:
Bachelor’s degree and 2 years of Quality experience in pharmaceutical, medical device or biotechnology industry
Beyond that, the additional preferred qualifications are:
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 efficiently with various levels
Basic understanding of analytical methods used in support of facility process monitoring
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
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Equal Opportunity Statement
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.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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.