The Senior Associate will be a member of the team that investigates Deviations in the Amgen Thousand Oaks Development Supply Chain Organization, including Drug Substance and Drug Product manufacturing, Supply Chain, Drug Product Assembly/Packaging, and Warehouse Operations. These investigations are compliant with regulatory requirements and include determination of scope, product impact, root cause, and effective corrective/preventative actions (CAPAs). 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 selected individual will:**
+ Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
+ Present investigations to regulatory inspectors and internal auditors
+ Clearly communicate investigation progress to impacted areas and leadership
**Desired skills/behaviors include:**
+ Ability to coordinate and effectively lead cross-functional teams through complex investigations, and complete milestones on-schedule.
+ Ability to build effective relationships across functions.
+ Demonstrated ability to quickly understand and clearly communicate complex issues
+ Negotiation skills when working with internal team members.
+ Navigate through ambiguity and provide a structured problem-solving approach.
+ Clear and concise technical writing
+ Master’s degree Or
+ Bachelor’s degree and 2 years of Manufacturing or Operations experience Or
+ Associate’s degree and 6 years of Manufacturing or Operations experience Or
+ High school diploma / GED and 8 years of Manufacturing or Operations experience
+ 4+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
+ Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
+ Strong interpersonal skills
+ Experience with problem-solving, root cause analysis, critical thinking, and quality systems.
+ Experience using TrackWise for Deviation investigations and CAPAs
+ Degree in Science or Engineering
+ Demonstrated project management ability
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.
We will ensure that individuals with disabilities are provided 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 accommodation.
Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.