Documentation Coordinator

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Full Time West Warwick, RI, US

Job Title: Documentation Coordinator Date: January 22, 2014

Division: Quality Reports to: Director of Quality

The Documentation Control Specialist is responsible for maintaining and controlling quality and manufacturing documentation in compliance with U.S. FDA regulations and current Good Manufacturing Practices (cGMP). This role ensures all documentation systems support regulatory readiness, data integrity, and product quality, particularly for OTC products. The position plays a critical role in batch record review, product release, audit support, and maintaining inspection-ready documentation at all times.

• Maintain and control all GMP documentation, including SOPs, work instructions, specifications, master batch records, and quality records, in accordance with FDA 21 CFR requirements and cGMP standards
• Manage the document lifecycle process (drafting, review, approval, issuance, revision, and archival) with strict adherence to document control procedures and data integrity principles
• Maintain departmental SOP indexes and ensure timely execution and tracking of periodic reviews (e.g., 2-year review cycle) to ensure ongoing compliance
• Assign, scan, index, and archive documents within the Quality Archive system, ensuring accurate, secure, and audit-ready records
• Maintain customer specifications via customer portals and direct communication, ensuring all requirements are current, approved, and properly controlled within the quality system
• Generate Annual Product Review (APR) reports, ensuring completeness, accuracy, and compliance with FDA expectations for product quality review
• Perform detailed batch record (batch packet) reviews for OTC products to verify compliance with approved master records, cGMP requirements, and data integrity standards
• Support and/or execute finished product release activities in accordance with FDA requirements and internal quality procedures
• Maintain and update the line set-up database to ensure alignment with validated processes and approved manufacturing instructions
• Ensure strict version control and traceability of all controlled documents to support regulatory inspections and audits
• Support FDA inspections, internal audits, and customer audits by providing accurate, complete, and readily retrievable documentation
• Identify and escalate documentation discrepancies, deviations, or non-compliance issues in accordance with quality system procedures
• Collaborate cross-functionally across the business to implement document changes and continuous improvement initiatives
• Ensure controlled access and proper distribution of GMP documents to authorized personnel only
• Perform additional duties as assigned by Quality Management

• Associate’s or Bachelor’s degree in Quality, Life Sciences, Engineering, or related field preferred
• 2–5 years of experience in document control within an FDA-regulated manufacturing environment (pharmaceutical, OTC, or similar)
• Strong working knowledge of FDA regulations, including 21 CFR and cGMP requirements
• Experience with batch record review and product release processes preferred
• Familiarity with data integrity principles and regulatory expectations
• Experience with electronic document management systems (EDMS) or Quality Management Systems (QMS)
• Strong attention to detail, with a high level of accuracy and compliance focus
• Proficiency in Microsoft Office (Word, Excel, Outlook; SharePoint or similar systems a plus)
• Understanding of FDA compliance and inspection readiness expectations
• Strong document control discipline with a focus on data integrity and traceability
• Audit readiness mindset and ability to perform under regulatory scrutiny
• Excellent organizational and time management skills
• Ability to identify compliance risks and elevate appropriately
• Strong cross‑functional communication and collaboration skills
• Continuous improvement and quality‑focused mindset

• Office-based role within an FDA-regulated manufacturing environment
• Routine interaction with production and quality operations on the manufacturing floor
• May require extended hours during regulatory inspections, audits, or product release activities