Senior Associate Manufacturing CAPAEV Thousand Oaks CA
Thousand Oaks, CA - USA
Job Summary
What you will do
Lets do this. Lets change the this vital role you will support deviations by owning the associated CAPA and EV records in the Amgen Thousand Oaks Manufacturing Clinical Supply Organization including Drug Substance and Drug Product manufacturing Supply Chain Drug Product Assembly/Packaging Quality Control and Warehouse Operations. This individual will play an integral role collaborating within a cross-functional team that includes Manufacturing Quality Assurance Process Engineering Process Development Analytical Sciences Quality Sciences Quality Control Supply Chain and Regulatory Affairs.
Responsibilities:
Manage deviation investigation CAPAs and EVs including assembling teams and compliant documentation of all findings.
Drive improvements to the investigation process
Defend investigation CAPAs/EVs to regulatory inspectors and internal auditors
Present complex topics clearly to large and small groups at all levels in the company
Build effective relationships across functions
Clear and concise technical writing
Additional Qualifications/Responsibilities
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.
Basic Qualifications:
Masters degree OR
Bachelors degree and 6 months of manufacturing experience OR
Associates degree and 2 years of manufacturing experience OR
High school diploma / GED and 4 years of manufacturing experience
Preferred Qualifications:
4 years related work experience (manufacturing process development or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
Degree in Science or Engineering
Experience leading teams
Demonstrated project management ability
Excellent written and verbal communication skills
Ability to work in a team matrix environment and build relationships with partners
Salary Range
86048.05USD -116417.95USDRequired Experience:
Senior IC
About Company
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