Production Operator II

Production Operator IIManufacture, process, inspect, document, and package freeze-dried plasma products in a controlled cleanroom environment. Operate production equipment used to thaw, transfer, lyophilize, and package plasma while maintaining product traceability and complying with current Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), approved procedures, and safety requirements. Support production readiness and continuous improvement through procedure review, accurate documentation, and authorized redlining of production procedures.• Champion a safety-driven culture and comply with applicable safety, environmental, and occupational health requirements.• Manufacture, process, inspect, and package product in accordance with approved procedures, production records, and established quality requirements.• Perform plasma-processing activities, which may include retrieving frozen plasma, operating thawing equipment, transferring liquid plasma, loading and unloading lyophilization equipment, and repackaging finished product.• Operate applicable production equipment, including balances/scales, bag sealers, thawers, hoods, lyophilizers, computers, label printers, and glove boxes, after required training and qualification.• Complete visual, dimensional, time, label, and documentation checks accurately and within established production standards.• Maintain complete and accurate product traceability and production records, including timely data entry in the BECS system or other approved systems.• Identify and promptly report quality issues, process deviations, equipment concerns, material defects, or workmanship deficiencies in accordance with established procedures.• Comply with GMP and GDP requirements, maintain required training records, and follow approved manufacturing and quality system procedures.• Review procedures and provide documented improvement feedback or authorized redlines in accordance with document-control requirements.• Maintain a clean, safe, and organized work environment, including adherence to gowning, PPE, contamination-control, and housekeeping requirements.• Meet established quality, productivity, and labor-time expectations while maintaining compliance and product quality.• Cross-train on multiple product lines and assist with peer training on approved procedures and equipment when qualified and assigned.• Perform other duties as assigned.• High school diploma or equivalent strongly preferred.• At least 6 months of relevant experience in biologics, pharmaceuticals, medical devices, or another highly regulated manufacturing environment required.• Working knowledge of GMP, GDP, and the importance of complete, accurate, and contemporaneous documentation.• Ability to read, understand, and follow policies, procedures, production records, and processes written in English.• Ability to use computers and approved manufacturing systems for product tracking and data entry; experience with BECS or a similar system is preferred.