What are the responsibilities and job description for the Document Review Specialist position at QCS Staffing?
Document Review Specialist - US, North Carolina - 6-12 Month Contract
Our client, a global pharmaceutical manufacturing organization are looking for a talented Document 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.
Essential Duties and Responsibilities for this role include, but are not limited to:
Our client, a global pharmaceutical manufacturing organization are looking for a talented Document 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.
Essential Duties and Responsibilities for this role include, but are not limited to:
- Ability to read and understand CQV and site quality procedures and align with the clients 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.
- Train CQV teams on GDP standards.
- Extensive experience 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
- Strong communication skills and ability to escalate issues as needed.
- Strong knowledge and experience successfully executing complex projects in a Pharma/cGMP environment.
- Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Word)
