Document Coordinator for Biologics Process Validation

2 weeks ago


Foster City, United States Fladger Associates Full time

Responsibilities:

  • Excellent employment opportunity for a Document Coordinator for Biologics Process Validation in the Foster City, CA area.
  • Department: PDM/ Technical Development/ Pivotal & Commercial Biologics
  • Create, revise, and implement procedures, best practices, and business processes for the Biologics Process Validation program
  • Act as a Project Manager to track and monitor Process Validation progress and deliverables
  • Coordinate Process Validation documentation: Prepare, edit, proofread, coordinate and adjudicate reviewer comments with author and subject matter experts
  • Perform Data Verification of completed Process Validation studies and reports
  • Create study templates to drive alignment
  • Work across Quality Assurance, Process Development, MSAT, and Contract Manufacturing Organizations

Experience:

  • Bachelor's degree in life sciences or related field
  • Minimum of four years of experience in biotechnology, process validation, Quality, or a related area
  • Excellent verbal and written communication skills
  • Strong quality mindset
  • Strong attention to detail
  • Strong project management skills
  • Must have understanding and application of GMP principles, concepts, and practices
  • Knowledge of biochemical manufacturing process and terminology
  • Knowledge and experience in process validation in highly regulated manufacturing environments



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