Document Coordinator for Biologics Process Validation in Foster City, CA

  • Title: Document Coordinator for Biologics Process Validation
  • Code: RCI-15651
  • RequirementID: 120659
  • Location: Foster City, CA 94404
  • Posted Date: 08/28/2024
  • Duration: 12 Months
  • Salary ($): 47.56 - 48.00 per Hourly
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  Job Description


Part time role: 20-25 hr/ week (Flexible hours)

HYBIRD ROLE

Job Title: Document Coordinator for Biologics Process Validation

Department: PDM/ Technical Development/ Pivotal & Commercial Biologics

Job Responsibilities:

  • 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

 

Knowledge & Skills Required

  • 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

 

Education & Experience

  • Bachelor's degree in life sciences or related field
  • Minimum of four years experience in biotechnology, process validation, Quality, or a related area


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