Specialist Corporate Quality
Experience: 5+ years of Quality, Engineering, or Manufacturing experience in GMP environment (Pharma, OTC, personal care, or dietary supplements) and 3+ years audit experience. Certification by the American Society for Quality (ASQ) as a Certified Food Safety Quality Auditor (CFSQA), Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Certified Pharmaceutical GMP Professional (CPGP) or similar required. Certified as a Preventive Controls Quality Individual (PCQI) is a plus.
Education: Bachelor's degree in a Science, Technology, Engineering, Mathematical, or related science/technical discipline.
• Knowledge of current GMPs, GLPs, ICH Q7, ICH Q10, ICH Q9, 21 CFR Part 11, and 21 CFR Parts 111, 210 and 211.
• Knowledge of quality principles, audit protocols, inspection procedures, data integrity principles, FDA regulations, and GMPs as applied to personal care, over-the-counter, and nutritional/dietary supplements industry.
• Possesses strong project and time management skills to ensure assigned activities are prioritized and completed with required timelines.
• Knowledge of continuous improvement tools/processes to participate in projects across functional areas of the business to resolve supplier issues.
• Critical thinker and active listener with ability to identify issues and provide solutions to a variety of problems.