QA Specialist

Thousand Oaks, CA
Jul 17, 2021
Required Education
High School or equivalent
Position Type
Full time


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.


What you will do

Lets do this! Lets change the world!

Provide Quality Assurance oversight for global distribution and supply chain operations for commercial and clinical biopharmaceutical products.

Ensure compliance to GMP regulations for area operations and associated processes, including warehousing and distribution, inventory management, and management of external relationships with Logistics Service Providers like storage depots and transportation service providers.

Typical tasks include:
  • Internal Quality Assurance support for GMP warehouse and inventory management operations

  • External Quality Assurance support for Logistics Service Provider problem reports, temperature excursions, facility changes, audit reports, etc.

  • Internal Quality Assurance support for Distribution functions in establishment and maintenance of specific product transportation lanes and modalities, including shipper qualification and management

  • Support investigations/deviation reports (Clinical Temperature Excursion Tracking System and Nonconformance)

  • Assess incoming product lots for compliance to cold chain temperature requirements

  • Manage QA product reserve sample inventory

  • Internal Quality Assurance support for creation and revision of GMP procedures and record generation, including document review, approval, and archival

The successful candidate will have experience working in multiple GMP databases


What we expect of you

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

Basic Qualifications

Doctorate Degree


Master's Degree & 3 years of cGMP experience


Bachelor's Degree & 5 years of cGMP experience


Associate's degree & 10 years of cGMP experience

OR High school diploma/GED & 12 years of cGMP experience

Preferred Qualifications
  • 3+ years of experience in a Quality Assurance role supporting GMP operations

  • Previous experience with quality system transactions (SAP, SM-LIMS, Trackwise, Documentum)

  • Strong technical writing skills, demonstrated experience creating deviation technical assessments or equivalent

  • Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and adhering to good documentation practices.

  • Educated in a science field with 5 years of experience in GMP/GCP operations or similarly regulated industry

  • Proficient with database use, including data input, archival, and query retrieval

  • Great attention to detail and high degree of accuracy in task execution and GMP documentation

  • Highly effective verbal and written communication skills, strong interpersonal skills

  • Ability to complete tasks autonomously, provide updates to area manager, and identify potential issues


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 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.

#Operations21Equal 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.