Gown Qualified Technical Operator, 2nd shift
Company: Renaissance LLC
Location: Lakewood
Posted on: June 21, 2022
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Job Description:
Renaissance LLCAll 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.OverviewOperate
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 union position and the hourly rate is
$22.91/hourThe ability to read, write and speak English is a
requirement of the job. Responsibilities--- 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 gowningo 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.QualificationsOne 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 Degree1 year of relevant
experience + Bachelor's DegreeRELEVANT EXPERIENCE
CONSIDERATIONS:--- Experience in pharmaceutical processing,
preferably clean room environment.--- Experience as environmental
monitoring technician, microbiologist and/or analytical.---
Mechanical experience in a cleanroom environment.PI180172454
Keywords: Renaissance LLC, Lakewood , Gown Qualified Technical Operator, 2nd shift, IT / Software / Systems , Lakewood, New Jersey
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