Better opportunity. Find it here.

Job Outline

The Quality Director is a highly critical and responsible position that oversees all Quality activities within a manufacturing company that specializes in confectionery and dietary supplement production. Assigned personnel will be required to maintain a high level of customer service while providing continuous quality improvements to ensure ongoing success on current and future production lines. The Quality Director will manage the members of the QA team and will ensure all staff receives adequate training on quality procedures, protocols, and required documentation.

Responsibilities

• Maintain Quality documentation and standards
• Establish quality and regulatory standards by studying product
• Review of cGMP documents to ensure company processes are compliant with applicable cGMP standards and regulations
• Develop and adhere to specification for raw materials, components, in-process checks, and finished products while working with cross-functional teams, customers, and external laboratories
• Verify inspections and testing of raw materials (Certificate of Analysis) to ensure vendor compliance with specifications
• Implement production line inspection standards by studying manufacturing methods
• Prepare quality reports by collecting, analyzing, and summarizing information and trends
• Train staff on quality procedures, protocols, and documentation
• Report on the performance of the quality system to executive management
• Act as a liaison to internal/external parties relating to the quality system
• Review batch documentation and disposition products to ensure quality
• Lead fast-paced, high-volume QA division to deliver optimal quality, training, and experience
• Drive continuous improvement of core processes to ensure manufacturing quality is maintained while efficiency is optimized
• Ensure annual outside auditing requirements are met for our current certifications (NSF, USDA
• Organic, Kosher, cGMP, etc.) and future certification
• Coordinate incident investigations and material reviews with cross-functional teams, executive team, customers, and suppliers
• Manage and train less experienced members of the QA team on quality procedures, protocols, and documentation
• Write and maintain Standard Operating Procedures (SOPs) for the manufacturing process and supporting controlled documents for warehousing, manufacturing, analyzing, and release processes
• Maintain sampling program for retention samples and finished products
• Develop and manage change control process working with ACC cross-functional team members
• Manage supplier and contract service qualification programs
• Other duties as assigned

Qualifications

• Bachelor’s Degree or equivalent experience
• Experience with QC measuring and testing equipment
• In depth understanding of quality control procedures and relevant legal standards
• Experience with MS Word, Excel, Project Management and Analytics software
• Must have Dietary Supplement GMP training (21 CFR 111) and working experience with the standards and requirements
• 4 or more years’ experience as QA director or similar assignment with in the dietary supplement field
• Extensive knowledge in a broad range of Dietary Supplements CGMP activities and Quality Systems
• Has current an FDA approved course for Preventive Controls Qualified Individual (PCQI) or is willing to train
• Internal and external auditing training/certification
• Working knowledge of NSF, USDA Organic, Kosher, 21 CFR 111 cGMP requirements and auditing