Job Title: QA Specialist/ Document Coordinator for Biologics Process Validation
Location: Foster City CA
Duration: 12 Months
Part time --- 20 to 25 hours a week
Description:
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
