Documentation Coordinator

Bradford Soap Works, Inc. is seeking a Documentation Control Specialist to maintain and control 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 include maintaining and controlling all GMP documentation, managing the document lifecycle process, maintaining departmental SOP indexes, assigning, scanning, indexing, and archiving documents within the Quality Archive system, maintaining customer specifications, generating Annual Product Review (APR) reports, performing detailed batch record reviews, supporting finished product release activities, maintaining the line set-up database, ensuring strict version control and traceability, supporting FDA inspections, internal audits, and customer audits, identifying and escalating documentation discrepancies, collaborating cross-functionally, ensuring controlled access and proper distribution of GMP documents, and performing additional duties as assigned by Quality Management.

Qualifications include an associate's or bachelor's degree in Quality, Life Sciences, Engineering, or related field, 25 years of experience in document control within an FDA-regulated manufacturing environment, strong working knowledge of FDA regulations, experience with batch record review and product release processes, familiarity with data integrity principles and regulatory expectations, experience with electronic document management systems or Quality Management Systems, strong attention to detail, proficiency in Microsoft Office, and strong cross-functional communication and collaboration skills.

Key competencies include 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, and continuous improvement and quality-focused mindset.

Working conditions include an office-based role within an FDA-regulated manufacturing environment, routine interaction with production and quality operations on the manufacturing floor, and may require extended hours during regulatory inspections, audits, or product release activities.