at Fagron Sterile Services in Wichita, Kansas, United States
Job Description
About the Job- Lead and coordinate daily manufacturing operations, including aseptic processing, batch compounding, filling, and equipment setup.
- Ensure compliance with 21 CFR Parts 210/211, FDA 503B guidance, USP <797>/<800>, and internal SOPs.
- Provide on-the-floor supervision, coaching, and training for manufacturing technicians.
- Review batch records, logs, and production documentation for completeness and accuracy.
- Partner with Quality and Engineering to resolve deviations, support investigations, and implement CAPAs.
- Maintain readiness for regulatory inspections and internal audits.
- Monitor equipment performance, material usage, and workflow to optimize efficiency and reduce downtime.
- Support implementation of process improvements, validation activities, and new product introductions.
