Amgen

Specialist QA

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Jun 04, 2021
Ref
R-117450
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.

Specialist QA

Live

Lets do this! Lets change the world!

Description

Provide high complexity tactical support to Site Leads across multiple Quality Systems and Processes.

Key Responsibilities
  • Perform tactical batch disposition activities in support of lot release

  • Lead and own NC, CAPA and Change Control records for External Supply Quality

  • Lead and drive Quality records to closure independently

  • Provide tactical information to the networks (i.e., metrics to QMR, MR, data verification, trending, periodic monitoring, APR)

  • Call out risks or roadblocks to management

  • Drive timely decision making using DAI principles

  • Drive continuous improvements and Amgen first mentality

  • Train on required Quality Systems (NCMS, CCMS, LIMS, SAP, and others as applicable)

Authority
  • Own Quality record content

  • Proposes revisions to SOPs in area of responsibility

Win

What we expect of you

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

  • Doctorate degree OR

  • Masters degree & 2 years of directly related experience OR

  • Bachelors degree & 4 years of directly related experience OR

  • Associates degree & 10 years of directly related experience OR

  • High school diploma / GED & 12 years of directly related experience

Preferred Qualifications:
  • 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry

  • Bachelors Degree in a Science Field

  • cGMP Experience

  • Ability to lead all aspects of multiple projects simultaneously

  • Able to successfully lead workload to timelines

  • Familiarity with basic project management tools

  • Ability to negotiate a position after taking feedback from multiple sources

  • Proven ability to consistently deliver timely, and high-quality results

  • Ability to operate in a matrixed or team environment

  • Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)

  • Ability to travel +/- 10% of time to domestic and international Amgen sites

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 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

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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.