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Associate Quality Control - Manufacturing Laboratory

Employer
Amgen
Location
Juncos, PR
Start date
Aug 9, 2022
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Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Associate Quality Control - Manufacturing Laboratory

Live

What you will do

Lets do this. Lets change the world. In this vital role you will support the Formulation and Filling manufacturing operations by completing tasks associated to the Analytical Laboratory for Manufacturing Drug Product organization. Tasks should be completed according to Standard Operating Procedures (SOPs) and Regulations in a Non Standard Shift GMP environment.

Specific responsibilities include but are not limited to:
  • Hands-on routine analytical testing of compendial methods to support manufacturing in-process activities and lot release.
  • Evaluate analytical results against applicable specification or acceptance criterion.
  • Operate laboratory instrument and equipment and performs basic troubleshooting, verification, standardization, calibration, and maintenance, accordingly.
  • Document completely, accurately, and concisely activities associated to analytical testing, equipment maintenances and sample/material transactions.
  • Review and approve analytical testing documentation.
  • Receive, store, dispense, deliver, transfer, reconcile, dispense, and dispose consumables inventory or ship materials per cGMP procedures and regulations.
  • Operate systems and resolve basic issues within LIMS, Maximo, CIMS and MES electronic systems.
  • Regularly draft and revise operating documents (e.g. SOPs, Guidelines, Work Instructions and Technical Reports).
  • Assist in the review of documentation for assigned functions (e.g. manufacturing orders, routine area audits, batch records and controlled forms).
  • May participate on cross-functional teams.
  • May initiate and own Laboratory Investigations, Deviations and CAPAs.
  • Maintain training proficiency and may train staff to perform hands-on tasks.
  • Identify and recommend and implement improvements related to routine functions.
  • Support Non-Standard Shifts including rotative weekdays and weekends.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Associate Manufacturing professional we seek is an individual contributor with these qualifications.

The Basic Qualifications are:

Bachelors degree

OR

Associates degree and 4 years of manufacturing and/or laboratory support experience

OR

High school diploma / GED and 6 years of manufacturing and/or laboratory support experience

Beyond that, the additional preferred qualifications are:
  • Educational background in Life Sciences (Chemistry, Biochemistry, Biology), Biomedical and/or Biotechnology.
  • Experience working in a GMP biotechnology, pharmaceutical or medical device industry.
  • Experience performing analytical testing of compendial methods.
  • Knowledge of basic computer systems including Microsoft Office, SAP, MES, LIMS, CIMS.
  • Organization skills and talent to perform assignments with a high degree of attention to detail.
  • Knowledge in Aseptic Techniques.

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 improve 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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith 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


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.

We will ensure that individuals with disabilities are provided 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 accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada 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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Find Us
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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