Must have 2-3 years experience in Drug Substance Manufacturing (Biotech)
2-3 years experience in Quality Assurance/Manufacturing/engineering
1-2 years experience in batch record review
Day to Day Responsibilities:
Electronic batch record review, documentation review, SOP and Manufacturing Procedure revision, approval, work order approval, and quality approval of Deviations/Nonconformances and CAPAs.
This role supports Amgen’s Quality Assurance department under the Operations organization providing daily oversight of Drug Substance Manufacturing production activities.
Under general supervision, the role provides support and compliance oversight to Manufacturing, Facilities, Engineering, Supply Chain, and other support staff in the execution of their processes, procedures, and use of quality systems.
Duties include electronic batch record review, documentation review, SOP and Manufacturing Procedure revision, approval, work order approval, and quality approval of Deviations/Nonconformances 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.
Schedule will need to be flexible to support 24/7 operations.
This includes days, swings, and night shifts.
"This posting is for Contingent Worker, not an FTE"