Compounding Operator 1

bioMérieuxLombard, IL
4d$23 - $31

About The Position

Operator 1 position is responsible for the preparation and formulation of Prepared Culture Media plates, bottle, and tubes in a cGMP compliant manner. The individual will perform or assist in equipment setup, operation, and cleaning throughout the Prepared Culture Media formulation process, complete production batches and corresponding documentation, and support routine production through tasks such as area cleaning, 5S activities, movement and weighing of materials, reworks, and material reconciliation.

Requirements

  • High School Diploma, GED or equivalent required
  • 2+ years of batching and compounding experience or experience mixing, weighing, and blending raw materials or ingredients to create finished products

Nice To Haves

  • Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.
  • Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.
  • Knowledge of FDA and/or GMP regulations preferred.

Responsibilities

  • Perform accurate calculations, verifications and mixing of chemical compounds for product formulations by following batch record instructions.
  • Set-up, operate and troubleshoot various types of kettles, scales, cleaning stations, autoclaves and basic laboratory equipment (graduated cylinder, pH meter, pipette, etc.).
  • Handle hazardous and non-hazardous raw materials to move them through the process flows in compliance with outlined procedures and safety standards.
  • Execute production activities per approved Manufacturing Directions while maintaining compliance with all job-related SOPs.
  • Perform ancillary cleaning and sanitization activities of chemical containers, production equipment and areas.
  • Ensure that all batch documentation is completed in an accurate, thorough, and timely manner and in accordance with Good Documentation Practices.
  • Perform and document all processes and procedures in a timely manner while maintaining compliance with all company and regulatory agency regulations.
  • Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns.
  • Maintain all work areas in a well-organized, clean, and tidy manner at all times in compliance with outlined 5S standards and cGMP requirements.
  • Comply with all OSHA and plant specific safety policies and procedures at all times, inform management of any safety hazards, and attend all required safety training.
  • Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties.
  • Collect accurate data for reports, charts and KPI’s and interpret the data to identify problems, and proceed with proper decision making.
  • Assist with executing validation protocols associated with packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state.
  • Perform other duties as assigned by Management.
  • Perform all work in compliance with company quality procedures and standards.
  • Perform other duties as assigned.

Benefits

  • A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
  • Company-Provided Life and Accidental Death Insurance
  • Short and Long-Term Disability Insurance
  • Retirement Plan including a generous non-discretionary employer contribution and employer match.
  • Adoption Assistance
  • Wellness Programs
  • Employee Assistance Program
  • Commuter Benefits
  • Various voluntary benefit offerings
  • Discount programs
  • Parental leaves
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