Job ID: #8936

QA Documentation Control Coordinator

Cambridge, MA
Science Science
Documentation / Technical Writing

 

Responsibilities of the QA Documentation Control Coordinator:

  • Coordinate document control and quality assurance documentation activities (paper and electronic).
  • Responsible for scanning, organizing, and uploading documents.
  • Troubleshooting location of documents and assign appropriate regulations
  • Assist in document archival of records at off-site storage per GxP regulations.
  • Coordinate the long-term storage archival of original documents and maintain document integrity, per mandatory retention policies.
  • Responsible for ensuring documents are complete, contemporaneous, and quality ensured.
  • Responsibility for ensuring compliance with company SOPs (Standard Operating Procedures).
  • Assist in writing and implementing SOPs.
  • Identify and interpret relevant document control guidelines.
  • Assist in the preparation and review of archival submissions.
  • Ensure documents that fail quality content review are effectively remediated by internal/external representatives.

Requirements of the QA Documentation Control Coordinator:

  • BS/BA Degree required in life sciences
  • Entry-level role with 0 to 5 years of industry experience.
  • Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment.
  • Working knowledge of current Good Manufacturing Practices (cGMP – 21 CFR Part 210/211), and Electronic Records; Electronic Signatures (21 CFR Part 11).
  • Proficiency in the use of Microsoft Office, PowerPoint, electronic document, and Training systems.
  • Experience with management and implementation of e-Quality Systems.
  • Experience with Veeva eDMS and ComplianceWire eLMS is preferred.

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    Commonwealth Sciences is a professional recruiting firm specializing in Life Science, Medical Device, and Engineering Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.