Documentation, Drug Manufacturing, FDA Requirements, GMP (Good Manufacturing Practices), People Management, Problem Solving Skills, Quality Assurance, Quality Assurance Methodology, Quality Control, Quality Management, Regulatory Compliance, Safety Standards, Sanitation, Statistical Process Control
RESPONSIBILITIES:
- Performs duties as QC Line Inspector with the addition of the following responsibilities.
- Assists QC supervisor in coordinating and monitoring activities of workers engaged in inspecting finished products on the line.
- Relieves QC Line Inspector when needed.
- Assists QC Line Inspectors with pulling samples and documentation.
- Assigns QC Line Inspectors to schedules and monitors department activities when Supervisor is not available.
- Verifies lot codes, expiration dates, and weights.
- Spot checks production lines for compliance.
- Ensures that all GMP and Safety standards are in compliance.
- Participates in weekly GMP, sanitation, and safety inspections throughout the production departments
- Interprets standards and procedures, and assists QCs inspectors in resolving technical problems.
- Reports unresolved problems to QC Supervisor.
- Reviews QC documentation
- Verifies QC equipment used in performing quality control tasks.
- Conduct work group meetings to relay management information to QCs, and solicit response to work-related problems.
- Other duties or responsibilities may be required as needed.
EDUCATION:
- High School diploma, some college level education preferred.
- Minimum 2-3 years of QA/QC experience.
EXPERIENCE:
- Demonstrated knowledge and application of statistical process control, quality assurance techniques and tools and quality management principles in a food, chemical or pharmaceutical manufacturing environment.
- Working knowledge of FDA regulations, Good Manufacturing Practices (GMPs) and HACCP
Minimum 2 years of industry or similar supervisory experience