The Gown Qualified Technical Operator will operate equipment to fill and seal product into containers within a controlled environment and maintain areas to a controlled status in accordance with all operational records, SOPs and cGMP requirements.
The Gown Qualified Technical Operator (GQTO) is responsible for the full spectrum of job duties currently held by Gown Qualified Operators. In addition, the GQTO will be responsible for environmental monitoring of the controlled areas, coordinating assigned tasks with team members and aseptic setups of rooms, product contact trains and component trains in the filling areas. This is a 1st shift position
• Exemplify Renaissance Core Values
• Performs job functions in conformance to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP) specifically associated with assigned tasks and generally as a Renaissance employee.
o Maintains qualifications/proficiency through continual training and monitoring.
• Performs in-process sampling such as weight checks, stopper height checks, machine challenges, etc.
o Following the specifications of the filling record, packaging record, or protocol.
• Regularly work within the controlled areas (classified and non-classified)
o Properly gown in conformance to the approved gowning procedures associated with the classification being entered.
o Exhibit good aseptic technique while working in assigned controlled area.
• Maintains control of environmentally controlled areas through cleaning and sanitization of the controlled environments on a regular basis.
o This includes sanitizing equipment/machine surfaces, ceiling, walls, floors, etc.
o Routine gowning
o Component and material transfer.
• Maintain complete and accurate documentation of assigned job functions in accordance to Good Documentation Practices (GDP).
• Operate equipment within assigned controlled non-classified and controlled classified areas.
o Including but limited to automated and manual washers, tunnels, fillers, cartoners (non-controlled) and labelers (non-controlled areas).
o Operate equipment in non-controlled areas as needed.
o Assist others through training and mentoring.
o Make minor adjustments (fill weights, torque, etc.) as needed to maintain process control.
• Monitor process controls regularly and report any abnormalities observed to area and/or quality supervision.
• Represents Operations as the process owner.
o Reports any observation made that can potentially harm the product, process, or business objective.
o Provides guidance to those observed not following procedures.
o Reports any safety concerns to area supervision and/or EH&S.
o Share operational knowledge with peers, new-hires, temporary staff members, and newly-appointed operators, as needed, to maintain efficiencies and cGMP compliance.
o Provides ideas for process improvements.
• Participate in team efforts to improve our work environment, product quality, efficiencies, and other initiatives identified as being beneficial to our business.
• Performs monitoring of processes within controlled areas to ensure control is maintained in these critical areas.
o Performs personnel monitoring within the controlled areas.
o Performs viable and non-viable monitoring during static and dynamic conditions.
o Obtains all supplies required to monitor the controlled areas.
o Delivers samples to the Microbiology Lab for further evaluation.
• Coordinates assigned tasks with team members as directed by reporting supervisor.
o Coordinates cleaning/sanitization activities.
o Coordinates job rotation.
o Coordinates filling activities.
• Performs aseptic setups of product and non-product contact parts.
o Filling equipment in sterile and non-sterile processes.
One of the following 3 scenarios are required to be considered for the role of a GQTO:
3 years of relevant experience + High School Diploma
2 years of relevant experience + Associate’s Degree
1 year of relevant experience + Bachelor’s Degree
Note: Personnel with experience must not have been disqualified from the aseptic areas in the past 12 months.