Position : Document Coordinator for Biologics Process Validation
Location: Foster City, CA, 94404 (Hybrid)
Duration: 12 months
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