Compounder

Job Description

Job Description

Description:

Performs compounding activities for pharmaceutical, medical device and healthcare products by weighing and dispensing raw materials, and producing batches using various manufacturing equipment in accordance with approved Batch Records, Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), and all applicable safety requirements. Maintains accurate documentation of manufacturing activities and performs cleaning and sanitization of equipment and production areas. Supports continuous improvement initiatives, new product development, process validations, equipment qualifications, and other manufacturing-related activities as assigned. Work is performed in a temperature-controlled environment.

• Weighs, measures, and dispenses raw materials for batch manufacturing.
• Operates balances, scales and other measuring devices to ensure accurate material usage.
• Stages and issues raw materials to manufacturing areas.
• Operates compounding equipment including portable mixers, kettles, tanks, pumps, and semi-automated processing equipment.
• Manufactures batches according to approved batch records, SOPs, and cGMP requirements.
• Completes manufacturing documentation using current Good Documentation Practices (cGDP) including: accurately, legibly, and in a timely manner.
• Performs equipment setup, operation, disassembly, cleaning, and sanitization.
• Cleans manufacturing rooms, weigh rooms, mix rooms and staging areas.
• Monitors weighing and compounding operations and reports deviations, equipment issues, safety concerns, or quality concerns.
• Safely charges raw materials into manufacturing vessels, including elevated tanks and kettles, using approved material handling and safety procedures.
• Participates in product development, process validations, equipment qualifications, investigations, and continuous improvement initiatives as assigned.
• Reviews and follows SOPs, batch records, safety procedures, and company policies.
• Operates material handling equipment including pallet jacks and approved lifting (both manual and self-propelled) or transport equipment.
• Participates in required safety training and promotes safe work practices throughout the manufacturing operation.
• Maintains compliance with all safety, environmental, quality, and regulatory requirements.
• Performs other duties as assigned.

• Ability to lift and carry up to 55 pounds and push and pull rolling loads requiring up to 50 pounds of force.
• Ability to frequently stand, walk, bend, reach, squat, kneel, climb stairs, and perform repetitive motions throughout the workday.
• Ability to climb and work safely on ladders, platforms, and elevated work areas.
• Ability to access manufacturing vessels, tanks, and equipment for charging, inspection, cleaning, and operation.
• Ability to wear required personal protective equipment (PPE), including safety shoes, safety glasses, gloves, hearing protection, and respiratory protection.
• Must be medically qualified and able to successfully complete respirator fit testing and training requirements.
• Requires High School Diploma or equivalent. Demonstrated ability to perform manufacturing-related mathematical calculations, including addition, subtraction, multiplication, division, fractions, decimals, percentages, ratios, unit conversions, and basic algebraic calculations.

All required PPE, including safety shoes, safety glasses, hearing protection, gloves, dust masks, respirators, is provided or reimbursed in accordance with company policy.

EO Employer M/F/Vets/Disabled

E-verify Participant.