Amgen Jobs

Mobile Amgen Logo

Job Information

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

Live

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

Win

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:

Master’s degree

Or

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

Thrive

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

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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.

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.​

DirectEmployers