Amgen

Specialist Quality Assurance

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Aug 30, 2019
Ref
R-82250
Required Education
Bachelors Degree
Position Type
Full time
The Specialist Quality Assurance will provide quality assurance support to the Product Quality (PQ) organization while working within a matrixed team environment. The Specialist QA will perform quality assurance responsibilities while reviewing and approving Product Quality documentation including: product specifications, in-process control specifications, specification technical reports, annual product reviews (APRs), international expansion forms, change control records, global distribution change records (GDCR), appendix Docs (APPXs for stability, APR, lot release, QE analysis, marketing application, master data sheets), Deviations, CAPAs/EVs, analytical comparability protocols, and analytical comparability reports. The Specialist QA will perform owner responsibilities related to change control records, Deviations, and CAPAs/EVs.

The Specialist Quality Assurance will also execute transactions in relevant GMP systems (CDOCS/VEEVA, Trackwise, etc.) and may include additional business process support for APRs and site audits.

Basic Qualifications

Doctorate Degree

OR

Master's Degree and 3 years in Quality Assurance, Quality Control or Manufacturing experience

OR

Bachelor's Degree and 5 years in Quality Assurance, Quality Control or Manufacturing experience

OR

Associate's degree and 10 years in Quality Assurance, Quality Control or Manufacturing experience

OR

High school diploma/GED and 12 years in Quality Assurance, Quality Control or Manufacturing experience

Preferred Qualifications

  • Familiar with pharmaceutical sciences, quality, compliance and regulatory requirements, associated with biologics and synthetic chemical manufacturing and QC testing.
  • B.S. in biochemistry, chemistry, biology, or a related protein or synthetic biotechnology sciences field or an equivalent level of biopharmaceutical experience with responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
  • Previous experience using VEEVA, Trackwise and other Amgen quality systems.
  • Knowledge of biopharmaceutical bulk and drug product development, manufacturing, and/or Quality Control Testing
  • Strong project management skills.
  • General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of biopharmaceuticals.
  • Previous experience working on a cross-functional team in a matrix environment.
  • Excellent written and verbal communication skills, including facilitation and presentation skills.


Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.

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.