Amgen Sr Associate - DSC NC in Thousand Oaks, California

The Sr Associate 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

  • Clear communication of investigations to impacted areas and leadership

  • Presenting investigations to auditors and inspectors

Basic Qualifications

Master's degree

OR

Bachelor's degree and 2 years of Biotech/Pharma experience

OR

Associate's degree and 6 years of Biotech/Pharma experience

OR

High school diploma / GED and 8 years of Biotech/Pharma experience

Preferred Qualifications:

  • Bachelor's or Master's degree in Chemical Engineering, Mechanical Engineering, the Physical Sciences, or a related field

  • 4 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

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.