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Quality Manager

Company: balchem
Location: Salt Lake City
Posted on: February 15, 2019

Job Description:

Principal Purpose: The Quality Manager has overall responsibility for the food safety, quality and efficiency of products manufactured at the site. He or she is responsible for all quality functions and oversight of the QC lab. Responsibilities include oversight of the inspection of raw materials and finished products to determine conformance to approved specifications; supervision of QC laboratory activities and management of lab technician(s); consultation with corporate regarding departmental priorities and initiatives. Essential Functions: Work with the plant manager to improve production, product quality and plant efficiency. Troubleshoot and determine the root cause of quality problems in production. Use risk based and statistical tools to improve product consistency and eliminate cross contamination. Review and approve proposed changes under a Change Protocol. In coordination with corporate document control, maintain, revise, approve and archive, as appropriate, master documents and controlled copies at the site. Ensure controlled documents are updated in a timely manner. Controlled documents include: Standard Operating Procedures (SOPs) Analytical Procedures Material specifications including raw materials and finished products Master Batch Records Master Labels CoAs including supplier CoAs and finished product CoAs QC Laboratory notebooks and associated raw data Maintain product specification sheets for site products that define routine and non-routine test protocols. Work with R&D on new product development including analysis of competitors material. When a new product has been launched as a standard product, ensure that the controlled documents (labels, specifications & (new) test methods, technical data sheets) and Chempax are updated and aligned as required. Ensure that material safety data sheets (SDSs) are issued or revised by corporate. Performs activities required of site preventive controls qualified individual (PCQI). Work with cross-functional site and corporate teams to ensure that SLC production is operating in accordance with current regulatory requirements - both domestic (21 CFR 507; cGMPs for Animal Food) and international. Audit against 21 CFR 507 as well as AAFCO guidelines. Act as the HACCP team leader for the Salt Lake City facility; maintain and update the HACCP/HARPC plan as required. Maintain 3rdparty certifications (e.g., FAMI-QS). Maintain awareness of current global events affecting feed quality. Collaborate with the regulatory compliance manager, on reviewing and approving the master labels. Claims on any master labels must be able to be supported by analytical test data (chemical, physical or microbial data obtained using internal resources or a contract lab). Conduct quarterly internal audits (self-inspection programs); issue reports/responses and manage corrective actions. On an annual basis, verify and validate prerequisite programs and conduct a mock recall. Host and document external and customer quality audits; provide information/corrective actions to customers as needed. Oversee and manage the inspection and disposition on incoming raw materials and finished products. File and archive inspections records, including suppliers CoA. Issue CoA for products as required. Evaluate and qualify new raw material suppliers. Assess performance of existing suppliers; verify accuracy of CoA provided by suppliers. Address customer complaints, technical questions and surveys while protecting proprietary information. Notify customers of significant changes and any non-conformances that could affect product performance. Make all customer communications through customer service. Assist the site operations manager to advance and promote the safety culture of the site, including the safety training of employees. Ensure that plant and laboratory tasks are performed as safely as possible. Enforce and follow safety policies and procedures including use of safety equipment (PPE) and equipment safeguards. Manage the site chemical hygiene program. Produce and maintain training documents, materials, slides, and records. Perform training (new hire and annual refreshers) on quality related issues as required. Oversee and supervise the work of the laboratory technician(s) to ensure that it is performed accurately, in compliance with the sites written procedures and in a timely manner. Maintain calibration and preventative maintenance programs for instruments. Document OOS investigations. Identify performance standards, goals, and learning targets for direct reports; issue an annual performance and learning process (PLP) assessment for each report. Manage the operations and expenses of the lab within the annual budget. Submit proposed budget for the quality laboratory as part of the annual budget cycle. Qualifications: BS in chemistry or related subject. 2-5 years industrial experience in manufacturing, QC/QA laboratory or other equivalent experience. Strong critical thinking and analytical skills. Skills: Demonstrated knowledge of manufacturing in a similar processing environment. Effective leadership, communication, interpersonal, organizational and planning skills Knowledge of SPC and process control software would be beneficial Physical Activities: No unusual physical activity requirements. Visual Acuity: Ability to distinguish colors and odors. Environmental Condition: Works inside most of the time, in an office and a laboratory environment. Occasionally in the production area with temperatures and noise above ambient levels, proximity to moving mechanical parts, with potential exposure to chemicals. PI107477049

Keywords: balchem, Salt Lake City , Quality Manager, Executive , Salt Lake City, Utah

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