Operator

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Gown Qualified Operator

Details

Gown Qualified Operator

Ocean County, NJ

3rd Shift

Pay: $26/HR

Duration: Direct Hire

QUALIFICATIONS:

• High attention to detail and strong organizational skills are essential for success in this role.
• Excellent written and verbal communication skills for effective interaction with third-party vendors and internal teams.
• Proficiency with computers and the ability to quickly learn and navigate software systems.
• A background in quality assurance (QA) documentation is preferred but not mandatory. Candidates with related backgrounds are encouraged to apply.
• Comfortable with paperwork-intensive tasks and maintaining accurate records.
• Ability to work independently and collaborate effectively within a team.
• Flexibility to occasionally work in the calibration lab environment to provide support and document processes.

RESPONSIBILITIES:

• Execute job functions in adherence to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP), both specific to assigned tasks and in alignment with the broader expectations for a Renaissance employee.
• Sustain qualifications and proficiency through ongoing training and monitoring.
• Conduct in-process sampling, such as weight checks, stopper height checks, and machine challenges, in accordance with the specifications outlined in the filling record, packaging record, or protocol.
• Regularly operate within controlled areas (classified and non-classified).
• Adhere to approved gowning procedures relevant to the entered classification.
• Demonstrate good aseptic technique while working in the designated controlled area.
• Manage environmentally controlled areas by routinely cleaning and sanitizing surfaces, including equipment/machine surfaces, ceilings, walls, and floors.
• Perform routine gowning and oversee component and material transfer.
• Maintain comprehensive and accurate documentation of assigned job functions, following Good Documentation Practices (GDP).
• Operate equipment within designated controlled non-classified and controlled classified areas.
• Utilize automated and manual washers, tunnels, fillers, cartoners (in non-controlled areas), and labelers (in non-controlled areas).
• Operate equipment in non-controlled areas as required.
• Provide training and mentorship, assisting others and making minor adjustments (fill weights, torque, etc.) as necessary for process control.
• Regularly monitor process controls, promptly reporting any observed abnormalities to area and/or quality supervision.
• Act as the process owner representing Operations.
• Report any observations that could potentially impact product, process, or business objectives.
• Offer guidance to individuals not adhering to procedures.
• Report safety concerns to area supervision and/or EH&S.
• Share operational knowledge with peers, new hires, contingency staff members, and newly-appointed operators to maintain efficiencies and cGMP compliance.
• Contribute ideas for process improvements.
• Participate actively in team initiatives aimed at enhancing the work environment, product quality, efficiencies, and other identified business benefits.

Benefits

Supplemental medical, Dental, Vision coverage

Term life Insurance plan

PTO accrual

401K

Gown Qualified Operator

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