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Document Review Specialist

  1. United States
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
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Document Review Specialist - Pharma - 12-Month Contract 

Our client is a large CDMO that specializes in cell culture and gene therapy. We are currently looking for Document Review Specialists with hands-on background in biotech and greenfield projects. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.


Main Responsibilities;
  • Ability to read and understand CQV and site quality procedures and align with FDB Large Scale Biologics operating principles and regulatory requirements.
  • Ability to work with an electronic validation system such as KNEAT or similar systems.
  • Conduct GDP reviews of test protocols pre and post execution to facilitate a timely review and approval process with Quality.
  • Utilize and own GDP checklist to track errors found in protocols and other documents. Update checklist as needed to ensure comprehensive list of potential GDP errors.
  • Conduct general documentation reviews of specifications, design documents, procedures, work instructions, etc. to ensure GDP requirements are met and standard formatting is maintained.
  • Liaise with CQV Leads, CQV Engineers and other departments to resolve GDP errors in protocols and documents.
  • Drive timely protocol closure for each phase of CQV.
  • Track and report weekly protocol closures.
  • Train CQV teams on GDP standards.
 

Requirements;
  • 3-5 years in a similar documentation review and/or Quality Assurance role for cGMP Documentation.
  • Prior experience with cGMP or in other highly regulated industries such as on Large Scale Projects and/or GMP operational facility.
  • Experience with liaising with other departments and engineers/QA, ensuring streamlined implementation of documentation review process or similar type process.
  • Willingness to step in a proactive manner for driving progress
  • Strong communication skills and ability to escalate issues as needed.
  • BA/BS in a related field and 3+ years’ experience successfully executing complex projects in a Pharma/cGMP environment.
  • Emphasis for this hire is on attitude (Positive Can-Do attitude) and strong collaboration.
  • Acts with detail-driven ownership and follow through.
  • Minimum of 3 years of cGMP documentation experience.
  • Kneat experience would be a bonus
  • Experience with complex projects and working in or around operating facilities.
  • Ability to keep work pace and meet deadlines. Good organizing and planning skills.
  • Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.


If this role is of interest to you, please apply now! 

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