Amgen

Specialist Manufacturing

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Sep 08, 2019
Ref
R-77861
Required Education
High School or equivalent
Position Type
Full time
The Specialist will assume the responsibility for investigating non-conformances (NCs) supporting the Amgen Thousand Oaks (ATO) Development Supply Chain (DSC) Organization, inclusive, but not limited to, Drug Substance manufacturing, Drug Product manufacturing, Device Assembly, Packaging, Labeling, Supply Chain, and Warehouse Operations. The individual is responsible for owing and leading the investigation into non-conformances which includes determining the scope, product impact, root cause, and identifying corrective/preventative actions (CAPAs) to eliminate the root cause. This individual will play an integral role collaborating within a cross-functional team that includes Manufacturing, Quality, Process Engineering, Process Development, Analytical Sciences, Quality Control, Supply Chain, and Regulatory Affairs.

The individual will be responsible for:
  • Own non-conformance records and investigation
  • Own investigation report to support the investigation
  • Ensuring records are comprehensive and compliant per procedures
  • Timely closure of records in relation to procedural guidance and/or disposition timelines
  • Right the first time investigation reports and records
  • Driving improvements to the investigation process
  • Clear communication of investigations to impacted areas and leadership
  • Presenting investigations to auditors and inspectors
  • Participating in NC trending activities
  • Participating in Lean Transformation activities


Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of drug product manufacturing or operations experience

OR

Bachelor's degree and 5 years of drug product manufacturing or operations experience

OR

Associate's degree and 10 years of drug product manufacturing or operations experience

OR

High school diploma / GED and 12 years of drug product manufacturing or operations

experience

Preferred Qualifications:
  • BS in Engineering, Microbiology, or other related field supporting analytical thinking, problem solving, and biologic manufacturing
  • Experience in Environmental Monitoring, Gowning, and Aseptic Behavior
  • 6 years of bio-pharmaceutical experience within bio-pharmaceuticals manufacturing facility
  • Analytically assess information and apply deductive reasoning
  • Clear and concise technical writing
  • Leadership skills to drive teams during the investigation
  • Ability to clearly communicate status of the investigation to leadership and to auditors and inspectors
  • Project management skills and being well organized


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.

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.