Document Review Specialist

QCS Staffing; North Carolina; On-site; USD 60,000 - 80,000; Full time

Job summary

A global pharmaceutical manufacturing organization is seeking a Document Review Specialist for a 6-12 month contract in North Carolina. The role involves ensuring compliance with quality procedures, conducting reviews, and collaborating with various teams. This is an exciting opportunity to contribute to a new manufacturing facility on the East Coast.

Qualifications

• Extensive experience in documentation review and/or Quality Assurance in cGMP environments.
• Proven success managing complex projects in Pharma/cGMP settings.

Responsibilities

• Read and understand CQV and site quality procedures.
• Conduct GDP reviews of test protocols before and after execution.
• Collaborate with CQV Leads and other departments to resolve GDP errors.

Skills

Communication

Project Management

Tools

Microsoft Word

Spreadsheets

Visio

Job description

Document Review Specialist - US, North Carolina - 6-12 Month Contract

Our client, a global pharmaceutical manufacturing organization, is looking for a talented Document Review Specialist to join their expanding team. With continued organizational growth and significant investment across their portfolio and capital programs, this is an exciting opportunity to contribute to their new manufacturing facility on the East Coast of the United States.

Essential Duties and Responsibilities include:

1. Read and understand CQV and site quality procedures, aligning with the client's operating principles and regulatory requirements.
2. Work with electronic validation systems such as KNEAT or similar.
3. Conduct GDP reviews of test protocols before and after execution to facilitate timely review and approval with Quality.
4. Use and maintain a GDP checklist to track errors in protocols and documents, updating it as needed.
5. Review specifications, design documents, procedures, and work instructions to ensure GDP compliance and proper formatting.
6. Collaborate with CQV Leads, CQV Engineers, and other departments to resolve GDP errors.
7. Train CQV teams on GDP standards.

Requirements:

• Extensive experience in documentation review and/or Quality Assurance in cGMP environments.
• Previous experience with cGMP or in regulated industries such as large-scale projects or GMP operational facilities.
• Experience liaising with other departments, engineers, and QA teams.
• Strong communication skills and issue escalation abilities.
• Proven success managing complex projects in Pharma/cGMP settings.
• Proficiency with computer tools (Spreadsheets, Word, Visio, Microsoft Word).

If interested, apply now for immediate consideration and further information.