Biologics Process Validation Specialist
4 weeks ago
Job Title: Biologics Process Validation Specialist
Type: Contract - 12 Month
Part-time hours a week
Location: Foster City, CA
Pay: $48.00-$50.00/hr
We are seeking a Biologics Process Validation Specialist for a very important client.
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
Benefits include:
- MEC/ACP Medical
- Voluntary Dental, Vision, Life, Supplemental Income
- 401k (must meet requirements)
- Sick leave as required by state/county
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