Compounding Operations Specialist

Swiss American CDMO•Carrollton, TX

5d•Onsite

About The Position

The 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.

Requirements

A minimum of 3-5 years of experience in a batch processing facility is required.
Proficient in compounding methodologies for skin care, OTC, wound care, and cosmetic products.
Knowledge of USP and other relevant regulations.
Excellent written and verbal communication skills.
Ability to effectively communicate with all levels of the organizations, from floor personnel to senior management.
Ability to analyze and interpret technical information, identify and troubleshoot problems, and implement solutions.
Strong attention to detail and accuracy.
Proficiency in Microsoft Word and other relevant software.
Must be able to lift up to 50 pounds.
Must be able to stand for extended periods

Nice To Haves

Associate’s degree in a relevant field preferred.

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.
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.