The Manufacturing Operator is responsible for supporting various manufacturing and compoundingactivities, including formulation, sterile filling, inspection, labeling, and packaging of sterile injectable drugproducts.
This position requires familiarity with quality-regulated manufacturing environments and current GoodManufacturing Practices (cGMPs). Manufacturing Operator I will perform and complete required batchrecords and associated documentation and will also be responsible for the movement of materials withinand 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 drugproducts.
- Monitor, evaluate, and adjust labeling and packaging equipment as needed to maximize qualityand 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 ofproducts.
- 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 classroomtraining.
- Alert production management or shift leads of any potential deviations to established processes orprocedures.
- 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
