Browse by job sector

Document Review Specialist

  1. United States
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
34799wr
Apply to this job Save job
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
Apply to this job Save job
Save as a job alert
List #1

Similar Jobs

Document Review Specialist

Salary

Competitive

Location

North Carolina

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

United States

Description

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

Reference

34799

Expiry Date

01/01/0001

Mark Chaumeton

Author

Mark Chaumeton
Mark Chaumeton

Author

Mark Chaumeton
Read more
Read more
Project Coordinator

Salary

Competitive

Location

North Carolina

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

United States

Description

Project Coordinator - Pharma - 12-Month Contract -  $80 - $100 per hour  Our client is a large CDMO that specializes in cell culture and gene therapy. We are currently looking for a Project

Reference

34820wr

Expiry Date

01/01/0001

Mark Chaumeton

Author

Mark Chaumeton
Mark Chaumeton

Author

Mark Chaumeton
Read more
Read more
GMP Project Manager

Salary

Competitive

Location

Philadelphia

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

United States

Description

GMP Project Manager - Pharmaceuticals - Philadelphia - 2 Years  Are you looking for the opportunity to work with a global biopharmaceutical company? This is your chance! Our client develops and

Reference

34810

Expiry Date

01/01/0001

Hannah Smith

Author

Hannah Smith
Hannah Smith

Author

Hannah Smith
Read more
Read more

Insights

Living and Working in Michigan

Living and Working in Michigan
Read more

10/25/2023

Living and Working in Chicago

Living and Working in Chicago

Read more

08/18/2023

life sciences testing laboratory

Why you should work in Commissioning, Qualification and Validation
Read more

02/07/2023

VIEW ALL

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.

Send your CV
Upload your CV