Manager, Quality Assurance Operations

Kite Pharma   •  

El Segundo, CA

8 - 10 years

Posted 241 days ago

This job is no longer available.

Job Description

Responsibilities

  • Receipt and disposition of incoming materials.
  • Review batch-related documentation, and ensures resolution of issues to release product.
  • Perform Product Disposition and Lot Closure.  Includes commercial and clinical products.
  • Oversee the packaging and shipping process; authorize shipment.
  • Provide QA oversight and approval of deviations.  Ensure deviations are properly initiated, investigated and resolved in accordance with established disposition timelines. 
  • Provide QA oversight and approval of CAPAs.  Ensures that associated CAPAs are initiated and resolved, as needed.
  • Provide QA oversight and approval of change records.  Ensures that change records are initiated and resolved, as needed.
  • Support, and as necessary participate in QA on the floor processes, including batch record review.
  • Ensure process control measures are in place and followed in product manufacturing.
  • Maintain metrics related to batch record review and product disposition in support of the Management Review.
  • Generate and update procedures and forms as needed.

Requirements

  • Bachelor’s degree in the biological sciences or related field and minimum of 7 years progressive experience in a pharmaceutical, biotech, or biologics operation, or equivalent education/work experience.
  • Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
  • Ability to effectively negotiate and build collaboration amongst individuals
  • Good interpersonal, verbal and written communication skills
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities