Production Support Specialist
2 weeks ago
The Production Support Operator ensures compliance with cGMP standards, maintains accurate and thorough documentation, and contributes to ongoing training and process improvement efforts to optimize production efficiency and product quality.
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.
- 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
- 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
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