Quality Coordinator-Document Specialist

Primary Duties and Responsibilities

• Administer document control activities including document issuance, revision control, archival, retrieval, and records retention.
• Maintain controlled documents, forms, logs, templates, and quality records in accordance with established procedures.
• Process approved document revisions and ensure current versions are properly maintained and accessible.
• Archive obsolete documents and maintain historical records in accordance with document retention requirements.
• Maintain document logs, revision histories, and controlled document inventories.
• Maintain training completion records and identify missing or incomplete training documentation.
• Routinely process quality related customer complaints, returns, and supporting documentation to appropriate Quality personnel for review and investigation.
• Maintain Approved Supplier records, supplier qualification files, agreements, audit records, and related documentation.
• Maintain CAPA, Change Control, complaint, supplier, audit, and training records.
• Administer annual document review schedules and maintain associated records and documentation.
• Maintain complaint, return, and associated quality records in accordance with established procedures.
• Create, revise, maintain, and distribute Safety Data Sheets (SDS) as required.
• Retrieve and provide quality records, documentation, and historical files in support of operational, customer, certification, regulatory, and internal requests.
• Maintain quality records in accordance with company procedures, regulatory requirements, and retention requirements.
• Verify required quality records are complete, appropriately approved, and properly maintained according to established procedures.
• Maintain records and documentation associated with quality systems, certification programs, audits, and compliance activities.
• Provide backup support for Quality department activities as assigned.

Qualifications

• Previous experience in document control, quality documentation, quality systems support, records management, or regulated manufacturing environments preferred.
• Previous experience within dietary supplements, food, cosmetics, botanicals, or related regulated industries preferred.
• Familiarity with FDA regulations including CFR 111, 117, 701, and related cGMP documentation requirements preferred.
• Experience supporting document control activities, controlled records management, archival systems, or quality documentation workflows preferred.
• Experience with QMS software, electronic documentation systems, and workflow management tools preferred.
• Working knowledge of document control practices, records management principles, and quality documentation requirements preferred.
• Experience supporting audit preparation, records retrieval, and quality systems documentation activities preferred.
• Strong computer skills including Microsoft Office, Google Workspace, ERP/QMS systems, electronic document systems, task management software, and reporting systems required.
• Bilingual English/Spanish preferred.