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Compounder II, 1st Shift Operations Specialist
2 months ago
Renaissance LLC is seeking a highly skilled Compounder II to join our team in Lakewood, NJ. As a key member of our production team, you will be responsible for executing bulk product batch processing, ensuring compliance with manufacturing procedures, and maintaining a safe and efficient work environment.
Key Responsibilities- Execute bulk product batch processing, adhering to established manufacturing procedures and protocols.
- 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 1-month time limit.
- 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 professional, courteous, and effective communication with all co-workers, customers, and contractors.
- Perform job responsibilities in a safe and efficient manner, maintaining a clean work environment.
- 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.
- 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.
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