Production Operator II

Lupin

1d•Onsite

About The Position

This role is responsible for executing manufacturing and packaging operations in compliance with cGMP requirements. The Production Operator II will perform a variety of tasks including verifying raw materials, assembling equipment, executing tasks according to batch records and SOPs, documenting operational parameters, performing in-process testing, monitoring production lines, packaging finished goods, and maintaining a clean and organized work environment. The position also involves supporting Quality Assurance and Laboratory operations, managing materials, and adhering to all health, safety, and compliance regulations.

Requirements

High school diploma.
Minimum of 1 year 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.

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 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 always required Personal Protective Equipment (PPE).
Maintain a clean, safe, and organized work environment.
Work collaboratively as part of a cross-functional team to meet production goals.
Perform additional duties as assigned by Manufacturing Management.