Production Support Specialist

5 days ago

Albuquerque, New Mexico, United States curiate Full time
Job Summary

The Production Support Operator plays a vital role in ensuring the production of high-quality sterile products. This position requires strong attention to detail, excellent communication skills, and the ability to work effectively in a team environment.

Key Responsibilities
  • Support the timely manufacturing of parenteral products, including vial preparation, fill line operation, lyophilizer loading/unloading, and vial sealing, all conducted in an aseptic environment according to Current Good Manufacturing Practice (cGMP).
  • Set up, operate, sanitize, and sterilize equipment and manufacturing areas within a cleanroom setting.
  • Prepare, wash, and sterilize vials, perform batch calculations and formulations, and ensure compliance with all relevant regulations and procedures.
  • Maintain current good documentation practices (cGDP) for all activities and actively participate in training and continuous improvement initiatives to enhance production processes and efficiency.
  • Sanitize aseptic and controlled areas using specialized solutions and equipment, adhering to sanitization protocols during sterile processing, and strictly following Standard Operating Procedures (SOPs) for all sanitization and documentation tasks.
  • Prepare, sterilize, clean, and decontaminate both dedicated and non-dedicated manufacturing equipment in a cleanroom environment.
  • Handle the compounding or formulation of drug solutions, using costly raw materials and hazardous chemicals, while adhering to safety protocols and wearing appropriate personal protective equipment.
Requirements
  • High school diploma or general education degree (GED)
  • Two (2) years related experience in production, manufacturing, and/or cleanroom preferred
  • Skilled in Microsoft Word, Excel, Outlook, and Access
  • Ability to quickly adapt and learn new manufacturing software systems
  • Fosters a collaborative and positive work environment
  • Champions change
  • Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members
  • Demonstrates strong attention to detail
Work Environment

The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job.

The employee may be required to work in an office, manufacturing, or warehouse environment.

The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions.

The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required.

Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand.

The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.

The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.

Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection.

All environments may be subject to working with or being exposed to cleaning agents.

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