Top Skills Required:
Day to Day Responsibilities:
- Experience working with Quality Systems
- 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
- Manufacturing production floor - preferably bio-tech
- Document review and approval- writing of SOPs and documents
- At least 1-2 years of experience in industry
- 75% on the manufacturing floor oversight
- electronic batch record review/batch record review
- GMP review and approval
- Quality contact for class 1 deviations and CAPAs
This role supports Amgen’s Quality Assurance program under the Manufacturing Plant QA organization providing daily oversight of Cell Bank, Pilot Plant (Cell Culture and Purification), Biosafety Development Lab production activities.
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 electronic batch record review, batch record review, SOP and MP revision approval, work order approval, and quality approval of class 1 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"