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QA Documentation Specialist III

2 months ago

Foster City, United States TekWissen ® Full time

Position: QA Documentation Specialist III

Location: Foster City, CA 94404

Duration: 12 Months

Job Type: Contract

Work Type: Hybrid (3 days onsite)

Pay Rate: $40/hr-$48/hr


Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our Biot ech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.


Job Description:

  • 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