Production Operator I

Essential Duties and Responsibilities

• Verify dispensed raw materials for each batch, ensuring accuracy and compliance with batch records and SOPs.
• Stage components and assemble production equipment required for manufacturing and packaging operations.
• Perform daily equipment checks and document usage in appropriate logbooks.
• Execute all tasks in accordance with Batch Records, SOPs, and cGMP requirements, ensuring proper documentation at all stages.
• Accurately document all operational parameters and process steps within batch manufacturing records.
• Weigh and record components, in-process materials, and finished product quantities.
• Perform routine in-process testing and inspections to ensure product quality and consistency.
• Monitor production lines for accuracy, stability, conformity, and product defects; take corrective actions when necessary.
• Assemble, stage, and distribute materials required for manufacturing and packaging activities.
• Package finished goods, including placing products into shipping containers and labeling shipments appropriately.
• Handle and properly dispose of production waste in compliance with SOPs at the completion of each batch.
• Palletize and transport finished goods within the facility using carts or pallet jacks, including movement to and from refrigerated storage areas.
• Clean production areas and equipment, maintaining proper documentation in cleaning logs.
• Support Quality Assurance (QA) and Laboratory operations as needed.
• Maintain GMP-compliant storage, issuance, and control of tooling and materials.
• Prepare and return partial raw material containers to the warehouse; properly deface and dispose of empty containers per SOPs.
• Verify the accuracy of materials received from dispensing and prior processing stages.
• Perform granulation, compounding, batch manufacturing, filling, and packaging activities using appropriate equipment.
• Conduct room and equipment inspections and maintain complete and accurate documentation.
• Adhere to all cGMP, regulatory, and company compliance requirements.
• Follow all Health & Safety policies, procedures, and training guidelines.
• Properly use required Personal Protective Equipment (PPE) at all times.
• Maintain a clean, safe, and organized work environment.
• Operate in alignment with the company's Code of Conduct and Business Ethics.
• Perform additional duties as assigned by Manufacturing Management.

Experience

• Experience in batch manufacturing, filling, and packaging operations for DPI or MDI products.
• Proficient in cleaning, setup, and operation of DPI or MDI related equipment, including: TRV blenders, Mixers and compounding systems, Manufacturing vessels, Filling machines, Blister filling and packaging lines, Filling and final packaging line assemblies.
• Understanding of blending uniformity, powder handling, and environmental controls required for DPI or MDI manufacturing.
• Ensures adherence to SOPs, batch records, and regulatory requirements throughout the production process.

Qualification and Experience

Education and Experience: High school diploma. Minimum of 5 years of experience and/or training; or equivalent combination of education and experience within a Production cGMP Environment.

• Knowledge of FDA, cGMP, GDP and SOPs related to job requirements.
• Ability to read and interpret documents in English such as safety rules, Standard Operating Procedures, batch records, and cleaning procedures.
• Proficient in English to sign and complete batch record documentation.
• Ability to speak and understand English effectively.
• Ability to add, subtract, multiply and divide using different units of measure to include averages of whole numbers, common fractions, and decimals.
• Ability to apply common sense thinking and understanding to carry out detailed written instructions.

Physical Requirements

• While performing the duties of this job, the employee is regularly required to sit, stand, walk, stoop, kneel, crouch, or crawl for a minimum of 8 hours.
• Employee will be subject to temperatures ranging from 2°C to 25°C on a daily basis and must be able to transport product in and out of refrigerated cooler within those temperature ranges.
• Employee must frequently lift and/or move up to 40 pounds.
• While performing the duties of this job, the employee is regularly exposed to moving mechanical parts.
• The employee may be exposed to fumes, airborne particles, toxic and/or caustic chemicals (PPE Provided).
• The noise level in the work area may be loud at certain times.
• The employee will be required at times to wear a full-face respirator and/or TYVEK or TYCHEM jumpsuits during cleaning operations, as well as eye protection, hearing protection, and other personal protective equipment (PPE) as required.
• The employee may be required to work additional hours from time to time, including weekends (O/T).
• Shift hours are subject to change due to operational needs.