Job Summary

　　Sr Operator will be responsible for the set-up, operation, cleaning of all Topical Department process equipment, including, but not limited to, the 125, and 1200 liter Becomix, 100 gal, and 1000gal 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 Sr 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 SOPs, 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 forms ensure 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 SOPs, 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 SOPs, 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 or GED -Required

　　Work Experience

　　5 years or moreexperience working in a pharmaceutical manufacturing environment, particularly with operating cream/ointment/lotion processing equipment -Required

　　Skills and Abilities

　　Familiarity with Becomix, Adams Mixers, Ross Mixers, Unimix, or other cream/ointment processing equipment 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 NOIs/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.

　　Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity