Top 3 Must Have Skill Sets:
Experience in biotech or pharmaceutical industry supporting manufacturing areas as plant quality assurance, manufacturing, quality control, or related staff.
Technical writing experience (i.e. deviation records, CAPA records, controlled documents)
Excellent verbal and written cross functional communication skil
Requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment. In accordance with applicable law, will provide reasonable accommodations to staff augmentation external workers 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 its operations, or its staff.”
*** Biotech/ Pharma experience required***
The Senior Associate QA role supports Quality Assurance program, providing daily oversight of Drug Substance manufacturing facilities at Thousand Oaks. 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 purposeful presence on the manufacturing floor, batch record review, SOP and MP revision approval, work order approval, and quality approval of deviations and CAPAs. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The incumbent will also represent functional area quality for the Bulk Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment to ensure workplace safety.
This staff member will be assigned to provide quality support during either day or night shift schedule periods, as operation support is 24/7.
Bachelors degree with 1 YOE
"This posting is for Contingent Worker, not an FTE"