Production Supervisor

American Regent, Inc.•Hilliard, OH

About The Position

The Production Supervisor is a member of the Manufacturing Team, which manufactures safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The role oversees all aspects of the manufacturing process, including component preparation, aseptic cleaning, compounding, filtration, and filling, following established production records. The supervisor performs and oversees manufacturing activities and provides signatory approval for work associated with the manufacturing process. The role provides direction, training, and mentorship to junior team members; ensures proper use of batch documentation; and troubleshoots manufacturing processes and equipment, making adjustments and minor repairs when necessary. The supervisor also coordinates personnel, schedules, supplies, and equipment to meet production needs while maintaining approved procedures and safe, sanitary, and aseptic conditions where required.

Requirements

  • High school diploma or GED equivalent.
  • One to three years of leadership experience, or demonstrated ability to lead, coach, or mentor a team or group.
  • Experience writing, reviewing, and executing standard operating procedures.
  • Ability to read Standard English documents, including standard operating procedures, maintenance schedules, and operating manuals.
  • Ability to wear cleanroom and protective gowning and equipment, including goggles, face shields, respirators, and protective gloves.
  • Maintain a clean-shaven appearance each working shift to properly wear tight-fitting respirators.
  • Ability to occasionally lift and/or move up to 50 pounds.

Nice To Haves

  • Bachelor’s degree in Pharmaceutical Science, Chemistry, (Micro) Biology, Engineering, or a related field.
  • Experience in manufacturing, the pharmaceutical industry, or with GMP/FDA regulations.
  • Chemical-handling experience, mathematical aptitude, and ability to assemble, troubleshoot, and perform minor repairs on manufacturing equipment.

Responsibilities

  • Supervise manufacturing activities for multiple products according to established operating procedures, delegating resources and participating in the process.
  • Train and mentor employees in all facets of the manufacturing process.
  • Review executed batch records and logbooks before submitting them for final production review.
  • Reallocate personnel based on production needs.
  • Create weekly activity schedules to meet production needs.
  • Maintain equipment and supply inventories and ensure they are available according to production schedules.
  • Ensure only approved materials, equipment, documentation, and procedures are used.
  • Ensure personnel perform only tasks for which they have accurate and approved training records.
  • Attend training programs required by company SOPs, procedures, and policies.
  • Perform other tasks and duties assigned by management.
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