Job Description

Description:

The Manufacturing Operator performs the set-up, operation, and cleaning of pharmaceutical processing equipment used in the manufacture of topical products, including creams, ointments, and lotions. The role is responsible for executing batch records, maintaining accurate GMP documentation, and following all applicable SOPs, cGMP requirements, and safety procedures to support safe, compliant, and efficient production.

Essential Functions:

• Execute the production schedule as planned, ensuring equipment/material availability prior to executing the days production. Perform all required tasks with minimal supervision.
• Responsible for 100% documentation accuracy on all GMP documents, such as bath records, log books, training records, in-process forms.
• Responsible for overall appearance of the processing suites, ensuring all suites, hallways, washroom, and storage areas a re clean and well kempt as per GMP guidelines and SOP procedures.
• Ensure that all processing equipment, room, scale, and environmental log books are promptly and accurately filled in – recording all activities.
• Responsible for reporting to the department supervisor any issue/concern, or potential issue/concern that may negatively impact the outcome of the successful execution of a batch. 
• The Operator will immediately notify the department supervisor if he/she observes any action or activity that is a violation of cGMPs, Procedures, or Safety, or any outside factor that may impact the safety, strength, efficacy of the product.
• Work closely with Technical Writer in generating detailed equipment SOP’s, focusing on set-up, operation, and cleaning

Additional Responsibilities:

• Secondary role, when not needed in Manufacturing, is to support other department activities, such as Packaging, and Pharmacy.
• Participate in the generation of “Task Qualification Checklists” for the Certified Trainer Program, and train new operators as required