Compounding Technician I (1:30p-10p)

American Regent, Inc.New Albany, OH
Onsite

About The Position

This entry-level position is a member of the Manufacturing Team, responsible for the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The role ensures aseptic and sanitary conditions are maintained, that manufacturing area and equipment records are accurate, and that safe, effective, and professional behavior is displayed. The Team Member will participate in all aspects of the Compounding Process, including dispensing and controlling raw materials, performing in-process QC sampling and testing, sterile dispensing and compounding, sterile filtration, equipment cleaning and sterilization, and line clearances. The Compounding Process is performed in accordance with established production records and company SOPs to manufacture sterile liquid pharmaceuticals. The Team Member will assist in all activities associated with the compounding process under the direct supervision of Senior Manufacturing Team Members.

Requirements

  • High School Diploma or GED equivalent required.
  • Ability to work in an environment where chemicals are handled and dispensed daily.
  • Excellent chemical handling and mathematical aptitude with the ability to assemble, troubleshoot and perform minor repairs on manufacturing equipment.
  • Ability to meet and maintain Class 100 Certification for sterile compounding/transfer (Hilliard facility) as well as maintain cleanroom gowning and respirator fit testing requirements.
  • Able to take feedback constructively and function in a team-oriented work environment.
  • Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
  • Ability to work overtime as needed.

Nice To Haves

  • Associate degree in chemistry or other science field is a plus.
  • 1-3 years related field work experience is preferred.
  • Experience with manufacturing technology such as HMI-PLC/SCADA controlled Isolation Barrier, Autoclave Sterilization, CIP Sanitization and SIP Sterilization preferred.

Responsibilities

  • Utilizes scales, balances, and load cells to weigh materials and perform batch additions of materials.
  • Performs aseptic filtration setup and filter integrity testing.
  • Utilizes blending, mixing and other homogenization technologies.
  • Performs mass/concentration calculations to determine batch dosing in accordance with material potency.
  • Stocks, gathers, and stages manufacturing supplies and equipment as needed.
  • Gathers, stages, and returns production materials as needed to support manufacturing activities.
  • Cleans and stores manufacturing equipment and cleans areas as needed to support manufacturing activities.
  • Understanding of basic process analytical methods (i.e., pH measurements and adjustments, dissolved oxygen content, etc.).
  • Attends all training programs as required by Company SOPs, procedures, and policies.
  • Perform any other tasks/duties as assigned by management.

Benefits

  • FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
  • Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
  • Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
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