Production Operator

Production General Operator

Location: Coral Springs, Florida

Type of Work: On-site

Schedule: Full-time; shift hours may change based on operational needs. Overtime and weekend work may occasionally be required. 2nd shift available

Type of Contract: Temp to perm

Description: The Production General Operator supports pharmaceutical manufacturing by preparing materials and equipment, operating production machinery, completing batch documentation, and performing manufacturing, filling, and packaging activities. This position works in a regulated production environment and must consistently follow Batch Records, Standard Operating Procedures, current Good Manufacturing Practices, quality requirements, and safety procedures.

Responsibilities and Duties:

• Verify dispensed raw materials for each production batch.
• Confirm that materials match Batch Records and applicable SOPs.
• Stage components and assemble equipment for manufacturing and packaging.
• Perform daily equipment inspections and document equipment usage.
• Execute production activities according to Batch Records, SOPs, and cGMP requirements.
• Record operational parameters and manufacturing steps accurately.
• Weigh and document raw materials, in-process materials, and finished products.
• Conduct routine in-process tests and inspections.
• Monitor production lines for accuracy, stability, conformity, and defects.
• Take appropriate corrective action when process issues are identified.
• Perform compounding, batch manufacturing, filling, and packaging activities.
• Package and label finished products for internal movement or shipment.
• Palletize and transport materials and finished products using carts or pallet jacks.
• Move products into and out of refrigerated storage areas.
• Clean production rooms and equipment and complete cleaning logs.
• Handle and dispose of production waste according to established procedures.
• Maintain GMP-compliant control and storage of tooling and production materials.
• Return partial raw material containers to the warehouse.
• Support Quality Assurance and Laboratory activities as needed.
• Maintain a clean, organized, and safe work environment.
• Complete required training and maintain qualification status.

Requirements:

• High school diploma.
• Minimum of five years of experience or training in a cGMP production environment, or an equivalent combination of education and experience.
• Knowledge of FDA requirements, cGMP, GDP, SOPs, and Batch Records.
• Ability to read and interpret safety procedures, production instructions, Batch Records, SOPs, and cleaning procedures in English.
• Ability to speak, read, and write English sufficiently to complete production documentation.
• Ability to perform basic mathematical calculations involving whole numbers, fractions, decimals, and units of measure.
• Ability to follow detailed written instructions.
• Ability to lift and move up to 50 pounds.
• Ability to stand, walk, sit, bend, stoop, kneel, crouch, or crawl during an eight-hour shift.
• Ability to work in temperatures ranging from approximately 2°C to 25°C.
• Ability to work around moving machinery, airborne particles, fumes, and chemicals while wearing required PPE.
• Ability to wear respirators, protective suits, eye protection, and hearing protection when required.

Skills:

• Pharmaceutical manufacturing
• Equipment operation
• Batch Record documentation
• Compounding, filling, and packaging
• In-process quality inspections
• cGMP and SOP compliance
• Material handling
• Attention to detail
• Safety awareness
• Team collaboration

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