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Document Coordinator for Biologics Process Validation

Foster City, CA 94404

Posted: 09/11/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 614298 Is job remote?: No Country: United States

Job Description


Target PR Range: 39-49/hr
*Depending on experience

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
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About Foster City, CA

Discover your next career opportunity in the vibrant job market of Foster City, California! Nestled in the heart of the San Francisco Bay Area, Foster City presents a perfect blend of scenic beauty and bustling industry. With top-notch companies, such as Visa and Gilead Sciences, calling this region home, job seekers can find a plethora of growth opportunities in various fields like technology, biotech, and finance. Explore job listings in this charming city known for its picturesque lagoons, beautiful parks like Leo J. Ryan Park, and the iconic Foster City Shell Mound. Indulge in the diverse culinary scene, catch a show at the Hillbarn Theatre, and cheer for the local sports teams like the San Francisco Giants at Oracle Park. Begin your career journey in Foster City today!

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