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Manufacturing Operations Specialist

2 months ago

Fort Collins, Colorado, United States Tolmar Full time

Job Summary

Tolmar is seeking a skilled Manufacturing Operations Specialist to join our team. As a key member of our manufacturing department, you will be responsible for ensuring the highest quality products for our patients.

Key Responsibilities

  • Work in a clean room environment with clean room gowning, adhering to strict quality control procedures.
  • Assist in setting up and operating labeling equipment for pre-filled syringes and/or vials, ensuring accurate and efficient production.
  • Collaborate with colleagues to set up and operate semi-automatic packaging equipment, maintaining a high level of productivity and quality.
  • Conduct in-process sampling and testing on the packaging line, identifying and addressing any quality issues promptly.
  • Assist with setting up, disassembling, and cleaning syringe filling/stoppering equipment, adhering to standard operating procedures (SOPs).
  • Prepare equipment and parts for sterilization, ensuring a safe and healthy working environment.
  • Assist with the bulking/filtration process before aseptic filling, maintaining a high level of quality and efficiency.
  • Maintain aseptic technique in an ISO 5-6 environment, adhering to cGMP standards.
  • Clean critical aseptic environments to maintain cGMP standards, ensuring a safe and healthy working environment.
  • Ensure product quality meets specifications, identifying and addressing any quality issues promptly.
  • Follow SOPs diligently, maintaining a high level of productivity and quality.
  • Participate in annual hazardous waste training, ensuring a safe and healthy working environment.
  • Perform other assigned duties, as required.

Requirements

  • High school diploma, GED or equivalent.
  • Manufacturing environment experience preferred.
  • Successful completion of a basic skill assessment.

Compensation and Benefits

  • Pay: $ per hour
  • Shift Differential: $ per hour