Skip to main content

Document Review Specialist

  1. North America, United States
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
34799wr

This vacancy has now expired

Document Review Specialist - Pharma - 12-Month Contract - $50 per hour

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! 

 #LI-MC1
Save as a job alert
List #1

Similar Jobs

Project Control Lead

Salary

Competitive

Location

Paris

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

France

Description

Project Control Lead - France, Paris - 18 Month Contract  Do you want to work at a leading global pharmaceutical manufacturer? If so, this is the assignment for you! Our global client with

Reference

37497

Expiry Date

01/01/0001

William Sweet

Author

William Sweet
Read more
Project Procurement Lead

Salary

Competitive

Location

Slough

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

England

London

Description

Project Procurement Lead - UK, Slough - 12 Month Contract  Our client, a leading partner to pharmaceutical, biotech and nutrition markets, has an exciting opening for a Project Procurement Lead

Reference

37562

Expiry Date

01/01/0001

Chris Bland

Author

Chris Bland
Chris Bland

Author

Chris Bland
Read more
Project Technical Manager

Salary

Competitive

Location

Singapore

Salary

Competitive

Sector

CAPEX Projects

Job type

Permanent

Location

Singapore

Description

Project Technical Manager - Singapore - Permanent Contract  How would you like the opportunity to work with in one of the largest biopharmaceutical projects in the country? If yes, then this is

Reference

37557

Expiry Date

01/01/0001

Suraj Chauhan

Author

Suraj Chauhan
Read more

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.