Quality & Regulatory Assurance
Quality & Regulatory Compliance has the responsibility to establish and maintain quality control, quality standards, inspection, test methods and procedures for controlling and maintaining the desired level of product quality for the company. S/he is responsible for writing and implementing the Standard Operating Procedures (SOPs) and maintaining compliance with Dietary Supplement Good Manufacturing Practice (cGMPs) Rule 21 CFR Part 111 to assure the quality and quantity of product produced.
JOB DESCRIPTION: Essential duties and responsibilities include the following. Other duties may be assigned.
Certificate of Analysis (C/A)
• Ensure conformance of C/A’s to established specifications
• Check incoming shipment C/A’s against AnMar specification or C/A of previous lot of product received
• Communicate with manufacturers/vendors on any non-conformances; ensure receipt of revised C/A’s
• Maintain “Manufacturers C/A s” folder on server
• Save incoming shipment - C/A’s on server
• Review C/A’s for shipments to specific customers
• Refer to available customer specifications/ C/A’s of previously shipped lots to ensure conformance
• Establish product specifications based on manufacturers’ C/A’s
• Create and sign specification sheets for products
• Update and maintain manufacturer’s documentation on server
• Complete Allergen and other regulatory questionnaires
• Provide quality and regulatory documentation to customers
• Monthly review of Kosher program with Rabbi
• Maintain current Kosher certificates on server
• Submit Kosher certification applications for new products and for renewal of facility certification
Pest Control and Temperature Humidity
• Sign off on pest control documentation on a monthly basis
• Track and maintain temperature and humidity records for the manufacturing and warehouse areas
• Update job knowledge by studying trends and developments in quality management
• Participate in educational opportunities and professional organizations
• Stay current with regulations, industry standards and expectations
• Enhance department and organization reputation by accepting ownership for accomplishing new and different requests as needed
Bachelor’s or Associate’s degree in related field of study. Quality background or work experience in a manufacturing environment a plus. This position requires someone that is highly organized and possesses strong written and verbal communication skills. Communicates information professionally and follows up in a clear and timely manner. Excellent attention to detail, analytical, organizational and time management skills. S/he should have good interpersonal skills and a passion for providing excellent service. Positive, energetic and enthusiastic attitude, proactive, responsible, results driven, problem/solution oriented, flexible to the needs of the business. Strong computer skills (MS Office, Word, Excel, PowerPoint), experience in IFS and GroupWise a plus. Multi-lingual such as Chinese would be an asset. The position is currently based in our Bridgeport facility. The facility may relocate to Shelton/Trumbull area, Connecticut in the future.
Please understand due to the high volume of responses we can only contact those most qualified for the position.
Thank you for applying and we will be happy to contact you if any other appropriate jobs become available
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