Job Title: QA Document Coordinator

Work Location: Plymouth County, Massachusetts

Summary:

We are seeking a detail-oriented and organized Quality Assurance (QA) Document Coordinator to join our Quality team. This role is essential for maintaining the integrity of our documentation systems and ensuring compliance with regulatory standards. The ideal candidate will be responsible for managing, reviewing, and archiving critical quality records to support our manufacturing and laboratory operations.

Responsibilities:

• Document Control: Manage the lifecycle of Standard Operating Procedures (SOPs), protocols, and reports, including drafting, formatting, routing for approval, and issuance.
• Compliance Review: Perform thorough reviews of manufacturing batch records, laboratory notebooks, and logbooks to ensure accuracy, completeness, and adherence to Good Documentation Practices (GDP).
• Archiving and Retention: Maintain the physical and electronic filing systems for all quality documentation, ensuring records are easily retrievable for audits and inspections.
• Change Management: Coordinate the document change control process, tracking revisions and ensuring that obsolete documents are promptly removed from use.
• Audit Support: Assist in gathering requested documentation during internal audits and external regulatory inspections.
• Database Management: Update and maintain Quality Management System (QMS) databases to track document status and training requirements.

Qualifications:

• Experience: Previous experience in document control or quality assurance within a regulated industry (such as Pharmaceuticals, Medical Devices, or Biotechnology).
• Knowledge: Strong understanding of cGMP (current Good Manufacturing Practices) and GDP requirements.
• Technical Skills: Proficiency in Microsoft Office Suite (Word, Excel, Adobe Acrobat) and experience with electronic Document Management Systems (eDMS).
• Attention to Detail: Exceptional proofreading skills and the ability to identify errors in complex technical documents.
• Communication: Strong verbal and written communication skills to collaborate effectively across different departments.
• High School Diploma or equivalent required; an Associate’s or Bachelor’s degree in a scientific or administrative field is preferred.

Published Category: Quality & Validation