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Quality Assurance Senior Associate

Thousand Oaks, CA
“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers 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 this company, its operations, or its staff.”
    
Top 3 Must Have Skill Sets:    
  •  Must have Pharma industry experience**
  •  Experience in manufacturing or quality fields within biotech or pharma industries.
  •  Complex decision making skills, ability to complete tasks autonomously, provide updates to area manager, and identify potential issues.
  •  Technical writing skills
  •  The ideal candidate would have applicable drug substance/drug product bio-tech manufacturing facilities as a QA or from a manufacturing background

Day to Day Responsibilities:    
    
The role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of their processes, procedures, and use of quality systems. Duties include purposeful presence on the shop floor, electronic batch record creation, batch record review, SOP revision approval, work order approval, and quality approval of minor deviations and CAPA records. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area quality for the Drug Product Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.

"This posting is for Contingent Worker, not an FTE"

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