General Description:
The Document Control & Quality Assurance (QA) Technician is responsible for maintaining controlled documentation and supporting quality assurance activities within the manufacturing facility. This cross-functional role ensures that quality management system documents are accurate, up to date, and compliant with company and regulatory requirements, while assisting with inspections, audits, nonconformance investigations, and continuous improvement initiatives.
The ideal candidate is highly organized, detail-oriented, and capable of working collaboratively across departments to maintain document integrity and support product quality objectives.
Document Control Responsibilities
- Maintain and administer the document control system, including procedures, work instructions, forms, specifications, and quality records.
- Review, process, distribute, and archive controlled documents in accordance with company procedures.
- Ensure document revisions are properly approved, implemented, and communicated to affected departments.
- Maintain document retention and record management systems in compliance with company and regulatory requirements.
- Support the creation, formatting, and standardization of manufacturing and quality documentation.
- Coordinate periodic reviews of controlled documents to ensure accuracy and relevance.
- Assist with preparation and organization of documentation for internal and external audits.
Quality Assurance Responsibilities
- Perform incoming, in-process, and final inspections of products and materials.
- Verify compliance with customer specifications, manufacturing standards, and quality requirements.
- Document inspection results and maintain quality records.
- Assist in investigating nonconforming materials and products, including root cause analysis and corrective actions.
- Support calibration tracking and maintenance of inspection equipment.
- Participate in internal quality audits and continuous improvement activities.
- Monitor quality metrics and assist in preparing quality reports.
- Work with production and supply chain teams to resolve quality concerns.
- Support implementation and maintenance of the Quality Management System (QMS).
Cross-Functional Responsibilities
- Serve as a liaison between Quality, Operations, and Manufacturing departments regarding document and quality-related issues.
- Train employees on document control processes and quality procedures as needed.
- Assist with regulatory, customer, and certification audits.
- Promote a culture of quality, compliance, and continuous improvement throughout the organization.
- Perform other duties as assigned.
Qualifications
Education and Experience
- High school diploma or GED required.
- Minimum 4 years of experience in document control, quality assurance, or manufacturing operations preferred.
Knowledge, Skills, and Abilities
- Knowledge of FDA regulations, GMP Standards and all requirements to dietary supplements.
- Strong understanding of document control principles and record retention practices.
- Knowledge of manufacturing quality systems and inspection techniques.
- Ability to read and interpret artwork proofs, specifications, and procedures.
- Proficiency in Microsoft Office applications and document management software.
- Experience using ERP, MRP, or electronic document control systems preferred.
- Strong organizational, analytical, and problem-solving skills.
- Excellent written and verbal communication skills.
- Ability to manage multiple priorities in a fast-paced manufacturing environment.
- High attention to detail and commitment to accuracy.
Physical Requirements
- Ability to sit, stand, walk, and use a computer for extended periods.
- Ability to occasionally lift up to 25 pounds.
- Ability to work in both office and manufacturing environments
Reporting Structure
Reports To: Quality Manager
Key Performance Indicators (KPIs)
- Document revision accuracy and timeliness.
- Audit readiness and compliance.
- Inspection completion rates.
- Nonconformance and corrective action closure effectiveness.
- Quality record accuracy and retention compliance.
- Internal and external audit performance.