- Entry level
- No Education
- Salary to negotiate
- Thousand Oaks
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
Bachelor’s degree and 2 years of Biotech/Pharma experience
Associate’s degree and 6 years of Biotech/Pharma experience
High school diploma / GED and 8 years of Biotech/Pharma experience
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.
About the company
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.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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