QA Documentation Coordinator

Job Title: QA Documentation Coordinator Department: Quality Assurance Reports To: Quality Manager Job Type: Full-Time, On-Site Shift: Monday - Thursday 6:30AM - 5:00PM Position Overview The QA Documentation Coordinator provides critical administrative and technical support to the Quality Department. This role focuses on maintaining the integrity of the Quality Management System (QMS) by organizing documentation, reviewing batch records for clerical accuracy, and preparing files for final approval. This is a support role ideal for a detail-oriented individual who ensures that all necessary paperwork is accurate, filed, and retrievable for audits. Key Responsibilities Document Control: Maintain the central file for Standard Operating Procedures (SOPs), ensuring all documents are current, signed, and properly version-controlled. Issue and track document change controls and route new documents for internal review. Batch Record Review: Audit Batch Production Records (BPRs) for administrative completeness (e.g., checking for missing signatures, blank fields, or calculation errors) before submitting to the Quality Manager for final disposition. Verify that all required Certificates of Analysis (COAs) and checklists are attached. Record Management: Manage record retention lifecycles, including physical filing and digital scanning of completed batch records, raw material qualification packets, and supplier documentation. Audit Support: Assist in the preparation of internal and external audits by retrieving requested documents and files. Maintain logs for customer complaints, deviations, and CAPAs to ensure timelines are tracked. Customer Support: Prepare standard document packages (COAs, specifications, compliance statements) for sales teams to send to customers. Assist in gathering data for customer questionnaires under the direction of the Quality Manager. Qualifications 1+ years of experience in an administrative or entry-level quality role within a regulated industry (Dietary Supplements, Food, Pharma, or Medical Device). High attention to detail and strong organizational skills. Proficiency with Microsoft Office (Word, Excel) and Adobe Acrobat. Ability to follow strict instructions and Standard Operating Procedures (SOPs). Preferred: Familiarity with 21 CFR Part 111 or cGMP documentation practices. Pay: $23.00 - $27.00 per hour Expected hours: 40.0 per week Benefits: 401(k) Dental insurance Health insurance Paid time off Work Location: In person