QualificationsEducation & ExperienceMust Speak Spanish - Associate’s or Bachelor’s Degree preferred (Life Sciences, Chemistry, Biology, Quality Management, or related field).
- 1–3 years of experience in QA or Document Control within the nutraceutical, pharmaceutical, food, or related regulated industry.
- Familiarity with cGMP, FDA 21 CFR Part 111/117, and quality documentation systems.
Skills - Strong attention to detail and accuracy.
- Excellent organizational and time-management skills.
- Knowledge of Good Documentation Practices (GDP).
- Proficiency in Microsoft Office (Word, Excel, Outlook).
- Experience with electronic document management systems (EDMS) is a plus.
- Strong communication skills (written and verbal).
Work Environment - Office-based position with regular interaction with production, QC, warehouse, and QA leadership.
- May require occasional presence in manufacturing areas to verify documentation or support audits.
Schedule - Full-time, Monday–Friday (hours vary by facility).
Physical Requirements - Ability to sit or stand for extended periods.
- Ability to lift up to 20 lbs for handling document boxes or files.
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The Quality Assurance (QA) Document Specialist is responsible for creating, managing, controlling, and maintaining all quality-related documentation in compliance with FDA, cGMP, and company standards. This role ensures accurate documentation practices to support manufacturing, quality control, regulatory compliance, and product release processes within a nutraceutical production environment.Key ResponsibilitiesDocumentation Control - Maintain, review, and update controlled documents such as SOPs, Batch Production Records (BPRs), Specifications, MMRs, Forms, Logs, and QA Policies.
- Ensure all documents comply with FDA 21 CFR Part 111/117, cGMP guidelines, and internal quality systems.
- Issue controlled documents to Production, QC, and other departments as needed.
- Manage document revision requests, approval workflows, and document obsolescence.
Record Management - Review completed batch records for accuracy, completeness, and compliance before final QA release.
- Maintain digital and physical filing systems for quality and production records.
- Ensure traceability and proper archival of all quality documents according to retention requirements.
Quality Assurance Support - Assist in internal audits by preparing necessary documentation.
- Support external audits (FDA, NSF, UL, third-party) by organizing and presenting required records.
- Monitor adherence to proper documentation practices (GDP) across departments.
Process Improvements - Identify documentation gaps and recommend corrective actions.
- Support the development of new documentation templates and workflows.
- Participate in continuous improvement initiatives relating to quality systems.
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