Documentation Coordinator at Bradford Soap Works Inc

West Warwick, Rhode Island, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Jul, 26

Salary

0.0

Posted On

08 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Document control, GMP compliance, FDA regulations, Batch record review, Data integrity, Quality assurance, SOP management, Regulatory inspection support, Audit readiness, Electronic document management systems, Quality management systems, Technical writing, Attention to detail, Cross-functional collaboration, Time management, Microsoft Office

Industry

Personal Care Product Manufacturing

Description

Bradford Soap Works, Inc. Position Descriptions Job Title: Documentation Coordinator Date: January 22, 2014 Division: Quality Reports to: Director of Quality Job Summary 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. Key Responsibilities * 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 Qualifications * 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) Key Competencies * 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 escalate appropriately * Strong cross-functional communication and collaboration skills * Continuous improvement and quality-focused mindset Working Conditions * 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

Responsibilities

The Documentation Coordinator manages and controls quality and manufacturing documentation to ensure compliance with FDA regulations and cGMP standards. This role is responsible for batch record reviews, document lifecycle management, and providing support during regulatory inspections and audits.