Gown Qualified Operator, 3rd shift

Job Locations US-NJ-Lakewood
Job ID
# of Openings
FLSA Status


The Gown Qualified Operator will 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 3rd shift position.


  • 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.
  • Performs in-process sampling such as weight checks, stopper height checks, machine challenges, etc.
  • Regularly work within the controlled areas (classified and non-classified)
  • Maintains control of environmentally controlled areas through cleaning and sanitization of the controlled environments on a regular basis.
  • 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.
  • 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

Note: Personnel with experience must not have been disqualified from the aseptic areas in the past 12 months.


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