Quality Assurance Manager

Quality Manager NOTE: This position does not offer relocation assistance. Only candidates living in the Northern Colorado area will be considered for this position. Position Summary: The Quality Manager will oversee all company Quality Assurance (QA) and Quality Control (QC) activities and provide guidance and direction for all products manufactured under regulatory (FDA, NASC) guidelines and GMP standards. This position will be hands-on in implementing the Quality Management System (QMS) and driving process and manufacturing improvements based on internal and external audit responses. The Quality Manager will provide strategic guidance across all departments of the company to ensure strict adherence to company standards. Essential Functions: - Develop, implement, and review all company policies, programs, and procedures related to the manufacturing of animal dietary supplement products as they relate to quality, compliance, and safety. - Develop, implement, and train the organization on Food Safety practices and principles. - Collaborate between R&D and Operations to ensure that final product meets all necessary standards, procedures, and specifications. - Identify and support required test methods, inspection criteria, risk assessments and 3 rd party lab results to ensure products meet regulations and specifications. - Create, train, and lead the company in cleaning and sanitation policies and practices. - Represent company in all external and 3 rd party audits from regulatory authorities and customer requests. - Oversee the quality review process for all ingredients, components, suppliers, and contract manufacturing partners. - Create and manage all required documentation related to product compliance, including but not limited to Certificates of Analysis, Ingredient Safety Data Sheets, supplier approval, internal release processes, etc. - Support operations and lead nonconformance and customer complaint investigations and approve all Corrective Actions and Preventative Actions (CAPA) and resolutions. Required Education and Experience: - Bachelor’s degree in food science, food technology, microbiology, chemistry, or related field. - 8 years’ experience in Quality functions related to food and/or dietary supplement manufacturing of finished products. - Significant experience with FDA, HAACP, and GMP 21 CRF Part 507, 111 and/or 117 regulatory standards, and with knowledge of SQF and NSF certification processes. - CO regulatory experience with CDPHE . - Knowledge and experience on international regulatory environments . - Strong understanding of laboratory practices and testing requirements. - Ability to organize and manage multiple projects. - Ability to work with allergens as defined by the FDA (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans). Manager Responsibility: - This position will have hiring, training and supervisory responsibilities. Travel: - Occasional overnight travel as required; should not exceed 20% of time. Work Authorization: - Must be authorized to work in the US. Physical Demands and Other Duties: - The work requires light physical demands with frequent lifting and/or moving of materials in the 10-40-pound range. While performing the duties of this job, the employee may be exposed to powders, fumes, or airborne particles, moving mechanical parts and vibration, and high noise levels. Knowledge and implementation of safety practices and personal protective equipment is critical.