Compounding Lead (2nd Shift)

Fagron Tech

Wichita (KS)

On-site

USD 52,000 - 72,000

Full time

14 days+

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Benefits offered by this job

Competitive salary
Comprehensive benefits
Growth opportunities

Job summary

Fagron US is seeking a detail‑oriented production professional to assist pharmacists and supervisors in the aseptic filling of sterile products within an ISO 7 cleanroom. You will help ensure GMP compliance, monitor training, and participate in procedural reviews while supporting continuous process improvements.

The role emphasizes leadership on the floor, adherence to batch records, and achieving Right First Time metrics in a fast-paced manufacturing environment.

Qualifications

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

Responsibilities

  • Assist pharmacists and room supervisors in aseptic filling and preparation within an ISO 7 environment.
  • Oversee ISO 7 cleanroom activities, including cleaning, materials preparation, and calibration checks.
  • Support adherence to SOPs, batch records, HR policies, and conduct timely corrections to meet RFT metrics.
  • Track training to ensure compliance and participate in bi-annual procedure reviews.
  • Provide on-the-floor leadership and coaching to technicians and help scale up initiatives.

Skills

ISO 7 gowning
GDP experience
cGMP manufacturing
supervision/lead
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.

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