Manufacturing Operator

Job Description

Job Description

The Manufacturing Operator  is responsible for supporting various manufacturing and compounding activities, including formulation, sterile filling, inspection, labeling, and packaging of sterile injectable drug products. 

This position requires familiarity with quality-regulated manufacturing environments and current Good Manufacturing Practices (cGMPs). Manufacturing Operator I will perform and complete required batch records and associated documentation and will also be responsible for the movement of materials within and out of clean  areas. 

KEY RESPONSIBILITIES 

• Perform aseptic techniques in a clean room environment. 
• Weigh, dispense, and mix chemicals according to product formulas outlined in batch records. 
• Stage, load, operating, and monitoring equipment for product formulations. 
• Set up processes and equipment for assembling and packaging sterile finished injectable drug products. 
• Monitor, evaluate, and adjust labeling and packaging equipment as needed to maximize quality and efficiency. 
• Inspect drug products, components, and labels for defects before and during production. 
• Safely transport packaging components from the warehouse and raw materials within clean areas, following Standard Operating Procedures (SOPs) and safety       guidelines. 
• Perform equipment start-up checks, calibration checks, and troubleshoot equipment as needed, including analytical balances, pH meters, and autoclaves. 
• Develop skills to work with and clean all semi-automated and automated equipment. 
• Perform cleaning and sanitization of designated clean areas in accordance with SOPs. 
• Complete documentation of activities and follow Good Documentation Practices (GDPs). 
• Conduct line clearances and complete necessary documents for accountability and traceability of products. 
• Comply with 503B guidelines, cGMPs, company standards, and all regulatory requirements. 
• Follow established cGMP gowning and de-gowning requirements for each production area. 
• Maintain and stay current on all necessary training, including GMP and work-related classroom training. 
• Alert production management or shift leads of any potential deviations to established processes or procedures. 
• Available to work overtime based on company needs.

EDUCATION / TRAINING  

• High School diploma or general education degree (GED) is required. 
• Demonstrated understanding of Good Manufacturing Practices (GMPs) and their application to manufacturing operations. 
• Knowledge of aseptic techniques (IV Certified, preferred). 
• Ability to work independently with little to no supervision. 
• Demonstrated ability to read, write, and speak English effectively. 
• 30 college hours or coursework in chemistry, biochemistry, or a related field is preferred. 
• Licensed and registered as a Pharmacy Technician is preferred 

WORK EXPERIENCE 

• Experience working in a high-paced manufacturing or clean room environment is preferred. 
• Familiarity with pharmaceutical, sterile compounded, and/or biologic drug products. 
• Familiarity with online training applications. 
• Proficiency with MS Office applications. 
• A minimum of 1 year of experience working in a quality-regulated pharmaceutical environment or facility is preferred. 
• Experience or participation in FDA or similar regulatory inspections is preferred.

ADDITIONAL QUALIFICATIONS   

• Self-Motivated and Detail Oriented. 
• Timely and Punctual. 
• Excellent Verbal and Written Communication. 
• Able to work Safely around Hazardous substances (drugs). 
• Capable of Lifting up to 50 lbs. and Standing for Extended periods of time for consecutive