Gown Qualified Technical Operator, 2nd shift
Company: Renaissance LLC
Posted on: June 24, 2022
All qualified applicants will receive consideration for employment
without regard to race, color, sex, sexual orientation, gender
identity, religion, national origin, disability, veteran status,
age, marital status, pregnancy, genetic information, or other
legally protected status.
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
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
This is a union position and the hourly rate is $22.91/hour
The ability to read, write and speak English is a requirement of
- 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
- 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
o Exhibit good aseptic technique while working in assigned
- 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
o Provides guidance to those observed not following procedures.
o Reports any safety concerns to area supervision and/or
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
o Obtains all supplies required to monitor the controlled
o Delivers samples to the Microbiology Lab for further
- Coordinates assigned tasks with team members as directed by
reporting supervisor.o Coordinates cleaning/sanitization
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
RELEVANT EXPERIENCE CONSIDERATIONS:
- Experience in pharmaceutical processing, preferably clean room
- Experience as environmental monitoring technician,
microbiologist and/or analytical.
- Mechanical experience in a cleanroom environment.
Keywords: Renaissance LLC, Lakewood , Gown Qualified Technical Operator, 2nd shift, IT / Software / Systems , Lakewood, New Jersey
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