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Senior Quality Assurance Specialist

2 months ago

Foster City, United States Integrated Resources, Inc ( IRI ) Full time

Job Title: QA specialist -Document Coordinator for Biologics Process Validation

Job duration- 12 months

Job location- Foster City, CA


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