Compounding Operations Specialist
Summary
Oversees pilot batch compounding, trains staff on equipment and safety, and maintains strict inventory and compliance controls in a regulated manufacturing environment.
Position Summary: Compounding Operations Specialist is responsible for overseeing the batching process for pilot batches, training compounders on methodologies and best practices, and ensuring strict adherence to inventory management protocols. This role blends technical expertise with leadership to enhance operational efficiency, optimize the training programs, and maintain precise inventory control. Additionally, it requires an understanding of the operating principles of all compounding equipment.
Essential Duties and Responsibilities:
- Oversee and execute pilot batch production processes, ensuring compliance with established protocols and safety standards.
- Collaborate with Process Engineering and Quality teams to refine processes and scale-up of new formulations for pilot runs.
- Offers hands-on experience in compounding to support efficiency improvements and batch validation.
- Ensure pilot batches are produced on schedule to meet customer expectations and follow FDA, GMP, and OSHA guidelines.
- Ensures that compounding equipment is maintained and requests repair when necessary.
- Ensures that the water purification system is operating within the quality guidelines established by Swiss American Products, Inc.
- Other duties may be assigned.
- Maintain accurate inventory records through systematic cycle counts and reconciliations to ensure material availability for production needs.
- Monitor and adjust inventory levels as required, collaborating with warehouse and procurement teams.
- Ensure accurate documentation and traceability of all material.
- Train and mentor compounders and weigh techs on batching processes, equipment operation, and safety protocols
- Support compounding leadership in evaluating team competency and adherence to process standards.
- Maintain Skills matrix for Compounders and Weigh Techs.
- Other duties may be assigned.