Gown Qualified Operator, 3rd shift
Company: Renaissance LLC
Posted on: January 19, 2023
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 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
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
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
--- 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
--- 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
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
--- Maintains control of environmentally controlled areas through
cleaning and sanitization of the controlled environments on a
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
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
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,
--- Military leadership, logistics, mechanical experience, and/or
training comparable to a manufacturing environment
--- Trade school or work experience in some construction
--- Microbiology or Chemistry Lab Experience.
Keywords: Renaissance LLC, Lakewood , Gown Qualified Operator, 3rd shift, Other , Lakewood, New Jersey
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