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Documentation Coordinator

240d4421 5b39 45d4 A140 4a3e00eab57f 19000101 000001 · West Warwick, RI, US, West Warwick, RI · Active · ADP Workforce Now Recruiting

Job facts

FieldValue
Company240d4421 5b39 45d4 A140 4a3e00eab57f 19000101 000001
TitleDocumentation Coordinator
Normalized title-
Department / team-
LocationWest Warwick, RI, United States
Work model-
Employment typeFull Time
Salary-
Statusactive
ATS providerADP Workforce Now Recruiting
Posted / first seen2026-04-08 / 2026-05-31
Changed / last seen2026-06-06 / 2026-06-06

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Linked records

Company240d4421 5b39 45d4 A140 4a3e00eab57f 19000101 000001
Source184105ff-2dc6-465c-8409-f46228c9c46e
ATS providerADP Workforce Now Recruiting

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

Full job record

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Org ID10a75bdb-3159-447f-b9ab-bed0884a5983
Source ID184105ff-2dc6-465c-8409-f46228c9c46e
Board ID184105ff-2dc6-465c-8409-f46228c9c46e
Provideradp_workforcenow
Provider Job Key574614
TitleDocumentation Coordinator
Normalized Title—
Statusactive
Activeyes
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CityWest Warwick
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Source URLhttps://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=240d4421-5b39-45d4-a140-4a3e00eab57f&ccId=19000101_000001&lang=en_US&type=JS&jobId=574614&jwId=9201948397707_1
Apply URLhttps://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=240d4421-5b39-45d4-a140-4a3e00eab57f&ccId=19000101_000001&lang=en_US&type=JS&jobId=574614&jwId=9201948397707_1
First Seen At2026-05-31 18:22:24Z
Last Seen At2026-06-06 12:15:53Z
Last Checked At2026-06-06 12:15:53Z
Last Changed At2026-06-06 12:15:53Z
Inactive At—
Source Posted At2026-04-08 02:16:00Z
Source Updated At—
Raw Payload Uris3://job-postings-prod-raw-590183727216/raw/provider=adp_workforcenow/board=240d4421-5b39-45d4-a140-4a3e00eab57f|19000101_000001/date=2026-06-06/2026-06-06T12-15-51-681Z-d6ae13907c53e0ca259f099c9d094b4e28c6795a21b5edb879c842fde8dbf850.json
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    "requisitionDescription": "<p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;' data-pasted=\"true\"><strong><span style=\"font-size:19px;line-height:115%;\">Bradford Soap Works, Inc.</span></strong></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;'><strong>&nbsp;</strong></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;'><strong><span style=\"font-size:19px;line-height:115%;\">Position Descriptions</span></strong></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;text-align:center;border:none;padding:0in;'><strong>&nbsp;</strong></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><strong>&nbsp;</strong></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><strong><span style=\"font-size:15px;line-height:115%;\">Job Title:</span></strong><span style=\"font-size:15px;line-height:115%;\">&nbsp;</span><span style='font-family:\"Times New Roman\",serif;'>Documentation Coordinator</span><span style=\"font-size:15px;line-height:115%;\">&nbsp;<strong>Date:</strong>&nbsp;</span><span style='font-family:\"Times New Roman\",serif;'>January 22, 2014</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><strong>&nbsp;</strong></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:1.0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;text-indent:-1.0in;'><strong><span style=\"font-size:15px;line-height:115%;\">Division: </span></strong><span style='font-family:\"Times New Roman\",serif;'>Quality&nbsp;</span><strong><span style=\"font-size:15px;line-height:115%;\"> Reports to: </span></strong><span style='font-family:\"Times New Roman\",serif;'>Director of Quality</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><strong>&nbsp;</strong></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><strong><span style=\"font-size:15px;\">Job Summary<br></span></strong><span style='font-family:\"Times New Roman\",serif;'>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.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><strong><span style=\"font-size:15px;\">Key Responsibilities</span></strong></p><ul type=\"disc\" style=\"margin-bottom:0in;\"><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>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&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Manage the document lifecycle process (drafting, review, approval, issuance, revision, and archival) with strict adherence to document control procedures and data integrity principles&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Maintain departmental SOP indexes and ensure timely execution and tracking of periodic reviews (e.g., 2-year review cycle) to ensure ongoing compliance&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Assign, scan, index, and archive documents within the Quality Archive system, ensuring accurate, secure, and audit-ready records&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Maintain customer specifications via customer portals and direct communication, ensuring all requirements are current, approved, and properly controlled within the quality system&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Generate Annual Product Review (APR) reports, ensuring completeness, accuracy, and compliance with FDA expectations for product quality review&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Perform detailed batch record (batch packet) reviews for OTC products to verify compliance with approved master records, cGMP requirements, and data integrity standards&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Support and/or execute finished product release activities in accordance with FDA requirements and internal quality procedures&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Maintain and update the line set-up database to ensure alignment with validated processes and approved manufacturing instructions&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Ensure strict version control and traceability of all controlled documents to support regulatory inspections and audits&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Support FDA inspections, internal audits, and customer audits by providing accurate, complete, and readily retrievable documentation&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Identify and escalate documentation discrepancies, deviations, or non-compliance issues in accordance with quality system procedures&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Collaborate cross-functionally across the business to implement document changes and continuous improvement initiatives&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Ensure controlled access and proper distribution of GMP documents to authorized personnel only&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Perform additional duties as assigned by Quality Management&nbsp;</span></li></ul><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><strong><span style=\"font-size:15px;\">Qualifications</span></strong></p><ul type=\"disc\" style=\"margin-bottom:0in;\"><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Associate&rsquo;s or Bachelor&rsquo;s degree in Quality, Life Sciences, Engineering, or related field preferred&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>2&ndash;5 years of experience in document control within an FDA-regulated manufacturing environment (pharmaceutical, OTC, or similar)&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Strong working knowledge of FDA regulations, including 21 CFR and cGMP requirements&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Experience with batch record review and product release processes preferred&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Familiarity with data integrity principles and regulatory expectations&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Experience with electronic document management systems (EDMS) or Quality Management Systems (QMS)&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Strong attention to detail, with a high level of accuracy and compliance focus&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Proficiency in Microsoft Office (Word, Excel, Outlook; SharePoint or similar systems a plus)&nbsp;</span></li></ul><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><strong><span style=\"font-size:15px;\">Key Competencies</span></strong></p><ul type=\"disc\" style=\"margin-bottom:0in;\"><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Understanding of FDA compliance and inspection readiness expectations&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Strong document control discipline with a focus on data integrity and traceability&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Audit readiness mindset and ability to perform under regulatory scrutiny&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Excellent organizational and time management skills&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Ability to identify compliance risks and escalate appropriately&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Strong cross-functional communication and collaboration skills&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Continuous improvement and quality-focused mindset&nbsp;</span></li></ul><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;'><strong><span style=\"font-size:15px;\">Working Conditions</span></strong></p><ul type=\"disc\" style=\"margin-bottom:0in;\"><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Office-based role within an FDA-regulated manufacturing environment&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>Routine interaction with production and quality operations on the manufacturing floor&nbsp;</span></li><li style=\"margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:normal;font-size:16px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;'>May require extended hours during regulatory inspections, audits, or product release activities&nbsp;</span></li></ul><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><br></p>\n",
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    "requisitionTitle": "Documentation Coordinator",
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    "requisitionLocations": [
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}
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