Gown Qualified Operator, 3rd Shift - Renaissance Lakewood LLC

Operate filling equipment in a controlled or non-controlled area to fill and seal product into containers as specified by batch record, and in accordance with all operational SOPs and cGMP requirements.

The Gown Qualified Operator is responsible for the full spectrum of duties in assigned filing room. This may include but is not limited to: set-up of room and equipment for production, operate equipment to meet product specifications and batch record requirements, ensures correct components and product according to production schedule and batch record, equipment and room cleaning and sanitization, etc

This is a union position and the hourly rate is $25.25/hour.

The ability to read, write and speak English is a requirement of the job. 

• 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, contingency 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.

One of the following 3 scenarios is required to be considered for the role of a GQO:
3 years of relevant experience + High School Diploma
2 years of relevant experience + Associate’s Degree
0 prior relevant experience + Bachelor’s Degree

Relevant Experience Considerations:
Relevant experience is defined by one or more of the following:
• Previous experience manufacturing product formulations and operating manufacturing related equipment (mixing tanks, pumps, homogenizers, etc.).
• Military leadership, logistics, mechanical experience, and/or training comparable to a manufacturing environment
• Trade school or work experience in some construction trades.
• Microbiology or Chemistry Lab Experience.