MFG Blender Operator I

Job Responsibilities

Manufacturing & Compounding Operations

• Perform pharmaceutical blending and compounding activities in accordance with approved batch records and SOPs.

• Manufacture batches containing active pharmaceutical ingredients (APIs), potent compounds, adhesives, solvents, and other regulated or hazardous materials.

• Assemble, disassemble, operate, clean, and sanitize blending and compounding equipment, kettles, tanks, mixers, pumps, and associated manufacturing systems.

• Perform raw material dispensing, weighing, staging, and verification activities using calibrated equipment and approved procedures.

• Conduct batch record calculations and verify material quantities, yields, and reconciliation activities.

• Perform in-process checks, sampling, and coat weight verification activities as required.

• Monitor and document operational parameters including temperature, mixing speeds, vacuum, pressure, and processing times.

• Support manufacturing operations within production and other departments as needed.

GMP Documentation & Compliance

• Accurately complete batch records, logbooks, equipment usage records, and all GMP documentation in accordance with Good Documentation Practices (GDP).

• Ensure all manufacturing activities comply with FDA, DEA, OSHA, cGMP, and company quality requirements.

• Maintain inspection-ready documentation and work areas at all times.

• Follow data integrity principles and ensure accurate, contemporaneous, and complete documentation practices.

• Comply with all company policies, safety procedures, and standard operating procedures while performing job duties.

• Operates in accordance with the company’s Code of Conduct, Business Ethics, and all established regulatory and compliance requirements.

Equipment & Area Maintenance

• Perform cleaning and line clearance activities for manufacturing equipment and production suites.

• Maintain blending rooms, equipment storage areas, and manufacturing spaces in a clean, organized, and compliant condition.

• Identify and report equipment malfunctions, process abnormalities, or safety concerns promptly.

• Support preventive maintenance and calibration activities as required.

Training & Team Support

• Work collaboratively with Manufacturing, Quality, Warehouse, Engineering, and EHS departments to support operational goals.

• Assist in training and supporting Blender Operator I personnel as directed.

• Participate in operational improvement and safety initiatives.

• Operates in accordance with the company’s Code of Conduct, Business Ethics, and all established regulatory and compliance requirements.

Safety & Environmental Compliance

• Properly use required personal protective equipment (PPE), including respirators, coveralls, gloves, hearing protection, and eye protection.

• Safely handle potent compounds, solvents, and hazardous materials in accordance with established safety procedures.

• Follow all environmental health and safety procedures, including hazardous waste handling and spill response requirements.

• Participate in safety initiatives, risk assessments, and operational improvement activities.

• Perform all other duties as assigned.