Document Coordinator for Biologics Process Validation
2 weeks ago
Job Location: Foster City, California
Job Duration: 12 months
Payrate: 40-45/hr on W2
Visa Status: No H1bs Other are fine
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
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