Gown Qualified Operator, 2nd shift
Company: Renaissance
Location: Lakewood
Posted on: June 23, 2022
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Job Description:
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 $22.91/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 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, 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 Degree0 prior relevant experience +
Bachelor's DegreeRelevant 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.
Keywords: Renaissance, Lakewood , Gown Qualified Operator, 2nd shift, Other , Lakewood, New Jersey
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