Manufacturing Lead (2nd Shift)

Manufacturing Lead (2nd Shift) Wichita, KS Job Details 11 hours ago Qualifications Quality control corrective actions Regulatory inspections Manufacturing management Document review (document control) Operations management Pharmaceutical regulatory compliance Internal compliance auditing Corrective and preventive actions (CAPA) Mid-level Improving operational efficiency Manufacturing standard operating procedures Continuous improvement Batch records Pharmaceutical plant experience Cleanroom Aseptic technique Training Leadership Compounding medications Regulatory compliance management Internal audits FDA regulations Full Job Description Who We Are Fagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries.

The goal of Fagron is:

"Together we create the future of the personalized medicine". Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient. From our position as market leader, we act locally and think internationally. 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 / , 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. Basic Qualifications Experience in sterile manufacturing, aseptic technique, or pharmaceutical production (503B or GMP environment preferred). Strong understanding of cGMP, cleanroom behavior, and environmental monitoring expectations. Demonstrated leadership or lead-operator experience. Ability to interpret batch records, SOPs, and regulatory requirements. What's on Offer? We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry. Ready for the challenge? Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. Fagron US is proud to be an affirmative action and equal opportunity employer.

Job Reference:

NA00351