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Quality Assurance Senior AssociateThousand Oaks, CA
Day to Day Responsibilities:
- 75% on the manufacturing floor oversight
- electronic batch record review/batch record review
- GMP review and approval
- Quality contact for events, minor deviations and CAPAs
- Day shift 8-5pm. Possibility of this position of being 2nd shift (2-11pm).
- This role supports Amgen’s Quality Assurance program under the Manufacturing Plant QA organization providing daily oversight Cell Culture and Purification.
- Under general supervision, the role provides support and compliance oversight to MFG and F&E staff in the execution of their processes, procedures, and use of quality systems.
- Duties include batch record review, SOP and MP revision approval, work order approval, and quality approval of events, deviations and CAPAs.
- The candidate will be required to evaluate compliance issues, provide recommendations, and assure progress to completion.
- The candidate will also represent functional area quality for the Bulk Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals.
- Candidates must have the ability to work in a team matrix environment and independently interact with various levels to drive items to completion.
"This posting is for Contingent Worker, not an FTE"
- Must have strong communication skills (both written and verbal)
- Experience making decisions independently and determining when to elevate to management, as appropriate in an environment that balances business need, quality and compliance risk
- At least 1-2 years of experience in industry