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Senior Quality Assurance Specialist

2 months ago

Foster City, United States Integrated Resources 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