Production Operator I

Job Description

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 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.

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Competencies

Collaboration

Customer Centricity

Developing Talent

Innovation & Creativity

Process Excellence

Result Orientation

Stakeholder Management

Strategic Agility