Compounding Lead (2nd Shift)

Fagron Group; Wichita (KS); On-site; USD 65,000 - 90,000; Full time

Job summary

Fagron US seeks a hands-on production-support role to oversee aseptic material preparation and manual filling in an ISO 7 environment. You will support pharmacists, supervise room staff, and help ensure strict GMP adherence on a fast-paced production floor.

The role requires standing in tight cleanroom spaces up to seven hours daily and maintaining qualifications for ISO 7 cleanrooms, GDP, and cGMP processes. A strong focus on RFT metrics and team coaching is essential.

Qualifications

• ISO 7 gowning experience required.
• GDP experience required.
• Strong understanding of cGMP pharmaceutical manufacturing preferred.
• Supervision or lead experience preferred.
• ISO 5 experience preferred.

Responsibilities

• Assist pharmacists and room supervisors to oversee all activities for preparation of materials and aseptic filling in an ISO 7 environment.
• Pass and maintain ISO 7 cleanroom entrance qualifications.
• Maintain ability to stand and move in tight cleanroom spaces up to 7 hours daily.
• Oversee ISO 7 cleanroom activities including cleaning of VLFHs and aseptically reconstituting, pooling and diluting drugs; manual filling; calibration checks; environmental plating; and communicating issues to management.
• Ensure compliance with SOPs, batch records, and HR policies; assist in disciplinary actions as needed.
• Meet Right First Time (RFT) metrics by reducing errors/deviations and completing corrections quickly.
• Review and maintain adherence to manufacturing schedules.
• Track employee training for compliance.
• Assist bi-annual reviews of procedures on the floor.
• Provide on-the-floor leadership to the production team.
• Assist in coaching/training technicians in manufacturing suites.
• Support process improvements and scale-up initiatives within the department.
• Manage personnel to operational standards and assist in performance evaluations.

Skills

ISO 7 gowning

GDP experience

cGMP knowledge

Supervision experience

ISO 5 experience

Job description

About the Job

Assist pharmacists and room supervisors to oversee all required activities for the preparation of materials and manual aseptic filling of compounding sterile products within an ISO 7 environment.

Key Responsibilities

• Successfully pass and remain qualified for entrance into the ISO 7 cleanrooms
• Successfully pass and remain media fill qualified
• Must be able to stand and maneuver around the tight spaces of a cleanroom for upwards of 7 hrs. per day
• Assist in overseeing all ISO 7 cleanroom activities including but not limited to: cleaning of VLFHs, the preparation of materials required to aseptically reconstitute, pool and dilute drug product, manual aseptic filling of drug product, performing calibration checks, environmental plating of operators, and communicating issues with management.
• Ensuring compliance to SOPs, batch records and HR policies, assisting in disciplinary action as needed.
• Meet Right First Time (RFT) metrics by reducing error / deviations and completing corrections quickly
• Review and maintain adherence to the manufacturing schedules
• Track employee training to ensure compliance.
• Aid in bi-annual reviews of procedures
• Provide on-the-floor leadership to the production team
• Assist in coaching and training of technicians in the manufacturing suites
• Support process improvements and scale up initiative within the department
• Manage personnel to operational standards and assist as needed in completing performance evaluations

Basic Qualifications

• ISO 7 Gowning experience required
• GDP experience required
• A strong understanding of cGMP pharmaceutical manufacturingpreferred
• Supervision or lead experience preferred
• ISO 5 experience preferred

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.