Amgen

Sr. Associate Quality Control

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Apr 24, 2022
Ref
R-143062
Discipline
Quality, Quality Control
Required Education
High School or equivalent
Position Type
Full time

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.

Sr. Associate Quality Control

Live

What you will do

Lets do this! Lets change the world!

Under general supervision, this position will support our Quality Control organization as a project manager with primary focus on analytical method transfer and analytical method validations. In addition this role will work closely with the HPLC, Bioassay, Compendial, Immunology, Microbiology, and Raw Materials groups in the successful and on time delivery of transfers and validations. Including managing project schedules, facilitating status update meetings, driving issue resolution, communicating and presenting to leadership, managing global conferences, reviewing and assimilating data, and coordinating performance monitoring activities.

Project management skills
  • On time delivery of global projects, timely communication of status (on-track/off-track), solutions driven.

Analytical Method Validation/Transfer Experience
  • Experience drafting analytical method validation/transfer protocols and reports

  • Microsoft Word and use of document management software (ie, EDM Quality)

Biotechnology Lab Experience
  • Experience in the lab which will serve them well in supporting analytical method validation/transfer documentation

Technical Writing
  • If not specific method validation/transfer document experience, more general technical writing experience of SOPs, Methods, Protocols, Reports

Additional responsibilities may be assigned and could include:
  • Generation of Certificate of Analysis for Raw Materials and Manufacturing release samples. This will include using SM LIMS to release lots in support of disposition

  • Monitoring of testing within Quality Control Labs against due dates

  • Assistance in support of Contract Laboratory testing which will include following up on testing that is in progress, monitoring of testing and issues, handling of results, etc.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The outstanding professional we seek will have these qualifications.

Basic Qualifications:

Master's degree

Or

Bachelor's degree and 2 years of Quality experience

Or

Associate's degree and 6 years of Quality experience

Or

High school diploma / GED and 8 years of Quality experience

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also 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 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.