Compounding Manager

This role will manage the daily and long term objectives of the Compounding production areas. Provide direction/guidance for manufacturing projects. Assure operations follow all Safety, GMPs, and SOPs etc. guidelines. Assist and develop team leaders and leads in the management of department personnel and floor operations. Assure all non-conformance investigations are thorough and accurately assess the situation as well as provide sound corrective actions.

Manage and track critical department metrics including spending, batch manufacturing performance, safety, and manufacturing quality metrics. Be a leader to assure team performance shows continuous improvement.

• Oversee, orchestrate, and successfully coordinate and synchronize the combined activities of the Compounding department involved in mixing/compounding, processing, pre-weighing and inventory control on a daily basis and ensure optimal use of personnel, materials, equipment, and time.
• Ensure all compounding activities comply with GMP standards, company policies, and regulatory requirements. Maintain the integrity of the quality system, overseeing documentation, corrective actions, and deviation reporting.
• Lead recruitment, training, performance evaluations, and the implementation of corrective actions, fostering a culture of excellence and continuous improvement.
• Champion a culture of safety and efficiency, implementing guidelines and continuously seeking process improvements to enhance productivity and product quality.
• Conduct regularly scheduled employee training encompassing GMP, SOP, SAFETY and cross training to expand employee capabilities.
• Performs other related duties as assigned

• Plan and execute daily pre-weigh/batching schedule efficiently and effectively in accordance with the planning department’s schedule and bulk rework as per R&D/account initiative.
• Monitor manpower allocations and usage per shift as per the number of work orders.
• Oversee the inventory control of raw materials, bases, and color bases at the Compounding storage location and ensure the accuracy of the system vs. physical count.

• Ensure all compounding personnel perform each task in accordance with GMP, regulatory requirements, and the quality system.
• Maintain documentation integrity on batching documents as executed by the compounding personnel.
• Sustain and improve the 5S programs that are suitable for Compounding operations. Maintain the 5S/housekeeping by the end of each shift, including pre-weigh skids and raw materials.
• As coordinated, collaborated, and monitored by the Technical Manufacturing Manager, ensure compounding personnel adhere to the compounding procedures and protocol of OTC batches.
• Provide resources for the line trial with R&D Chemist or with customers on-site as coordinated/supervised by the Technical Manufacturing Manager.
• Prepare the compounding area for GMP inspection audits by Health Canada/FDA and major customers with assistance and guidance from the Technical Manufacturing Manager.

• Reinforce safety protocols and procedures to all compounding personnel.
• Actively participate in regular workplace inspections as assigned by the Health and Safety department.
• Monitor and observe any environmental and equipment conditions that may pose major safety risks to personnel and company property. Report observations directly to the Manufacturing Director.
• Report any daily operational issues to the maintenance department regarding equipment breakdowns.

• Conduct training on GMP/Safety protocols to new personnel as part of the onboarding protocol.
• Perform training sessions on new GMP/SOP/workplace safety/equipment safety procedures as well as 5S/housekeeping to all…