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Manufacturing Process Operator
at Renaissance Pharmaceuticals
Lakewood, NJ

Manufacturing Process Operator
at Renaissance Pharmaceuticals
Lakewood, NJ

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Description


Overview

The Manufacturing Process Operator reports to the Production Supervisor through the line leader. This person is responsible for safely operating all equipment on any packaging line in controlled and non-controlled areas outside the sterile cores. This person will also be responsible for the inspection of filled product under controlled conditions.

Responsibilities

  • Exemplify Renaissance Core Values
  • Run equipment as per the validated machine settings.
  • Gown and work within controlled non-sterile areas. (i.e. Scrubs, Head Cover, Facial Hair Cover (if applicable), shoe covers, gloves, Tyvek hood, coveralls, boots and safety goggles)
  • Inspect micro-suppository for the presence of the product, voids, length, broken suppositories.
  • Maintains qualifications/proficiency through continual training and monitoring.
  • Document machine related downtime as required.
  • Ensure only acceptable product is allowed downstream.
  • Communicate mechanical issues or process deviation to Supervisor, Line Leader and mechanical staff.
  • Maintain complete and accurate documentation of assigned job functions in accordance to Good Documentation Practices (GDP).
  • Make minor mechanical adjustments.
  • Responsible for cleaning equipment and the area around the equipment.
  • Follow directions with minimum Supervision and complete all paperwork required
  • Keep an accurate record of component and product waste.
  • Maintain a good attendance record.
  • Other duties as assigned
  • Ensure that in the performance of daily activities, that all applicable cGMP are followed. Immediately report to the Line Leader, Quality Assurance or the Production Supervisor any behavior or practice that is not cGMP compliant. Maintain knowledge of cGMP by attending required training sessions


Qualifications

High school degree, with aEntry level - no experience required. Prefer at least 2 years of relevant experience in the pharmaceutical industry

minimum of 3 years of relevant experience; or equivalent combination of advanced education (ie, coursework in Life Sciences) and experience.

Ability to pass basic skills test.

Must have 20/20 eyesight (with or without corrective lens) and able to distinguish colors for the inspection process and be capable of consistently identifying small particles of foreign material.

Education:

SAMPLE JD TEXT: Bachelor's Degree in related field required with a minimum of ## years of relevant experience in the pharmaceutical industry or equivalent combination of education and experience. Master's Degree preferred.

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