Amgen Sr. Associate Quality Control- Incoming 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 Quality Control – Incoming Inspection
What you will do
Let’s do this. Let’s change the world. In this vital role you will work with a team responsible for the Incoming Quality Control sampling and inspection processes of GMP raw materials, components, packaging and printed materials used in our Manufacturing and Packaging plants. In addition, will work cross-functionally to support multiple customers and stakeholders including Supply Chain, Quality Assurance, Process Development, Engineering and Quality Control.
SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
Perform routine sampling and inspection of raw materials, components, devices, drug substance, drug product and printed materials.
Work closely with Supply Chain Procurement, QA Disposition, Dispensing, Receiving, Shipping and Packaging to ensure daily warehouse operations are well coordinated between each function.
Operate specialized equipment (i.e. Optical Comparator, Keyence, Nikon, Instron, NIR).
Perform raw material/component sample shipments, testing and Incoming batch records documentation review per standard operating procedures.
Participate in regulatory inspections/audits, initiatives and projects that may be departmental or organizational in scope.
Identify routine functions, operational issues and process improvement opportunities, along with the solutions and actions to address them.
Train new staff members and ensure they are qualified to execute all tasks assigned.
Provide technical guidance on Incoming area processes.
Serve as the group’s primary point of contact to internal and external customers, for complex operational issues, including investigation and solution.
Participate in GMP document revision process.
Support the introduction of new method transfers, reports, validations, and protocols.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Associate Quality Control professional we seek is an individual contributor with these qualifications.
The Basic Qualifications are:
Bachelor’s degree & 2 years of manufacturing and/or quality experience
Beyond that, the preferred qualifications are:
Educational background in Life Sciences and/or Engineering.
Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines.
Strong knowledge and experience in sampling and inspection processes for raw material, components, drug substance, drug product and devices per procedures and regulations.
Strong skills in systems such as SAP/ERP, eBR, LIMS, Trackwise, Coldstream and applications such as smartsheet and excel among others.
Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels.
Ability to organize and prioritize multiple responsibilities, tasks and projects simultaneously to perform assignments and meet deadlines.
Strong communication (both written and verbal), facilitation and presentation skills.
Strong Leadership including influencing and negotiating.
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.
Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.