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Documentation Review Specialist

  1. United States
Raleigh
  1. Contract
Competitive
  1. Life Sciences
33186

This vacancy has now expired

Documentation Review Specialist - Raleigh, USA - 12-Month Contract 

Our client, a global Pharmaceutical manufacturing organization are looking for a talented Documentation Review Specialist to join their expanding team. 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.


Responsibilities:
  • 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:
  • Experience and contacts;
  • 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.
  • Acts with detail-driven ownership and follow through. Knowledge and Skill;
  • Minimum of 3 years of cGMP documentation experience.
  • Experience with complex projects and working in or around operating facilities.
  • Proven success working well in a team environment with flexibility to react to changing business needs.
  • Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Word)

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



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