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Compounder II, 2nd Shift Specialist

2 months ago

Lakewood, New Jersey, United States Renaissance LLC Full time
Job Summary

We are seeking a highly skilled Compounder II to join our team at Renaissance LLC. As a key member of our production team, you will be responsible for executing bulk product batch processing, ensuring the highest quality standards are met.

Key Responsibilities
  • Execute manufacturing procedures to process bulk product, adhering to strict quality control measures.
  • Operate processing equipment, perform manual and automated cleaning, sanitizing, and sterilization of tanks and equipment.
  • Perform integrity testing of filters using automated filter integrity test equipment.
  • Assemble or disassemble equipment, configure equipment for washing, and autoclaving.
  • Demonstrate aptitude and capability to perform multiple tasks simultaneously.
  • Pass sterile gowning qualification within a specified timeframe.
  • Perform EM monitoring and testing of grade C and D clean rooms.
  • Utilize knowledge to actively demonstrate process trouble-shooting capabilities.
  • Maintain accurate and complete documentation in fulfillment of all duties.
  • Understand and comply with current SOP and GMP requirements relevant to the position.
  • Maintain a clean work environment, performing routine maintenance on process equipment.
  • Review MBRs throughout process to assure compliance to good documentation practices.
  • Be available for unscheduled and scheduled overtime throughout the work week and weekend when requested.
Requirements
  • Prerequisites: One of the following is required to be considered for the role of a Compounder II:
  • 4+ years of relevant experience + High School Diploma
  • 0 years of relevant experience + Bachelor's Degree
  • 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.
  • Aseptic manufacturing experience preferred.
Compensation

Yearly Salary