The Senior Operator will be responsible for the set-up, operation, cleaning of all Topical Dept process equipment, including, but not limited to, the 125, and 1200 liter Becomix, 100 gal, and 1000 gal Ross Mixer, the 500 liter Adams Mixer, and any/all other processing equipment required in the manufacture of creams, ointments, and lotions.Sr Operator will execute the Production Batch Record as written without deviation, and document all specified tasks/actions as required. The Senior Operator will be the Lead person in the room in partnership with the other operator performing the "checked by" task. The Sr Operator will ensure all cGMP's, SOP's, OSHA, regulations are followed at all times during the execution of the batch.
Essential Functions:
Responsible for having a full and thorough understanding of the functionality and operational capabilities of all processing equipment in the Topicals Department, executing the production schedule as planned, ensuring equipment/material availability prior to executing the days production. Perform all required tasks with minimal supervision, acquainted with all equipment related SOP’s, from set-up, cleaning, and operation. Continually monitor the actions of the operators in the course of executing the batch record, to ensure compliance.
Responsible for 100% documentation accuracy on all GMP documents, such as bath records, log books, training records, in-process formsensure that all processing equipment, room, scale, and environmental log books are promptly and accurately filled in – recording all activities.
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.
Work closely with Technical Writer in generating detailed equipment SOP’s, focusing on set-up, operation, and cleaning.
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 Sr 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.
Additional Responsibilities:
Participate in the “Certified Trainer Program” when implemented. Requirements include, generating a “Task Qualification Checklist”, completing a “Train the Trainer” program, working closely with the Technical Writer in generating new and detailed SOP’s, training new operators on all processing equipment, and evaluating said performance.
Support other department activities, such as Packaging, Pharmacy, training of other employees, etc.
Participate in the generation of “Task Qualification Checklists” for the Certified Trainer Program, and train new operators as required.
Work all necessary overtime, as directed by the department Supervisor, whether it be on a daily basis, or over the weekend in order to execute the production plan and meet customer delivery demand.
Education:
High School Diploma or GED: Required
Experience:
5 years or more in experience working in a pharmaceutical manufacturing environment, particularly with operating cream/ointment/lotion processing equipment is required.
Skills:
Familiarity with Becomix, Adams Mixers, Ross Mixers, Unimix, or other cream/ointment processing equjipment a plus. - Advanced
Must have mechanical ability. - Advanced
Must have ability to read, write, perform basic math calculations, and communicate in English. - Intermediate
Familiarity with Becomix, Adams Mixers, Ross Mixers, Unimix, or other cream/ointment processing equipment a plus. - Advanced
Specialized Knowledge:
Previous pharmaceutical operations experience Gmp & SOP familiarity Previous experience operating pharmaceutical processing equipment, particularly mixers, blenders, processors, etc • Lean Six Sigma training/experience a major plus • Excellent written skills • Must have good verbal communication skills in English • Must posses analytical problem solving and trouble shooting skills. Lean six Sigma experience a major plus • Must have the ability to interact with individuals from all levels throughout the organization • Must be a motivated self starter, requiring little to no supervision to accomplish their daily tasks • Must have the ability to generate reports/response to NOI’s/investigations • Must have the ability to train/cross new operators on set-up, operation, cleaning of equipment - previous “train the Trainer” experience a major plus • Must have great attention to detail. • Must be an excellent “team” player – assisting co-workers when necessary, and providing training and guidance as needed, particularly to new operators.
