Position Summary
The QA Administrator supports the Quality System by managing documentation, records, and compliance activities. This role ensures accuracy and integrity of quality-related data and assists in audits, training, and regulatory reporting.
Key Responsibilities
- Maintain and manage the Quality System (QS) database for documentation related to manufacturing, testing, inspection, validation, and product development.
- Ensure accuracy and completeness of records; update and archive files as needed.
- Initiate, route, approve, and release change requests; analyze impact and ensure compliance.
- Investigate and document customer complaints, deviations, nonconformances, and CAPAs.
- Manage training records and conduct training sessions.
- Create forms to support regulatory, quality, and R&D functions.
- Compile and distribute reports; support Annual Product Review documentation.
- Review batch records and investigate discrepancies.
- Assist with internal and external audits.
- Perform other administrative duties as assigned.
Qualifications
Associate degree in science or math (with at least two years of college-level chemistry), or a Bachelor of Science degree.Minimum of 2 years of experience in quality control or quality assurance (preferred).Familiarity with FDA GMP requirements and basic statistical principles.Strong communication and interpersonal skills.Proficiency in Microsoft Office and other software tools (e.g., spreadsheets, word processing, MRP systems).Certifications such as Six Sigma, Quality Auditor, Quality Inspector, or Quality Process Analyst are a plus but not required.