Equipment​/Sterile Operator I-3rd Shift

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Description:

Job Title:Equipment Sterile Operator I - 3rd Shift (Sunday
-Thursday )

Location:Cherry Hill, NJ

Job Type:Full-time

Req :12194

ABOUT US

We continue to be committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Equipment/Sterile Operator I. In this role, you will be responsible for the full spectrum of duties while following cGMP’s, SOP/Job Aids and Safety requirements.

JOB PURPOSE

Equipment/Sterile Operator I position involves a minimum of twelve (12) months of supervised training in the preparation of components used in the filling and compounding process, filter integrity testing, product sterilization and aseptic gowning. Training will start with component preparation duties and progress into responsibilities for MIT Testing, preparation of miscellaneous items, tubing, and filters, sterilization of finished product and aseptic gowning.

The training activities would be expected to progress in the following manner or until which time the incumbent has completed the required qualifications and has demonstrated the confidence and proficiency to conduct his or her work independently:

Phase I– Demonstrate complete familiarity with the preparation of components, including but not limited to proper documentation, proper bagging and sealing processes and ability to inventory/manage through the RF Gun process. Once qualified, employee will be expected to prep components and scan to appropriate staging/storage, prep and usage area using the RF system.

Phase II– Demonstrate complete familiarity with the testing of filters for Membrane Integrity Testing (MIT) and use of filter integrity test units, including but not limited to proper documentation, recognition of filter types/class and ability to interpret results. Once qualified, employee will be expected to conduct filter testing and document appropriate test results. Additionally, demonstrate complete familiarity with preparation of miscellaneous items, tubing, and filters required by Filling or Compounding.

Phase III– Demonstrate complete familiarity with product terminal sterilization on all finished product autoclaves including but not limited to proper documentation and ability to interpret chart readings and recorders. Once qualified, employee will be expected to sterilize product loads in accordance with applicable procedures.

Phase IV– Demonstrate the ability to aseptically gown including but not limited to aseptic gowning, proper sanitization, and proper plating.

Upon successful completion of the above training program and applicable job qualifications, the incumbent will receive an hourly rate increase.The employee will utilize the skills developed as an Equipment/Sterile Operator I to learn the skills of an Equipment/Sterile Operator II and clean, prepare and sterilize equipment and perform sterile operations on a rotational basis with co-workers or as directed by area management.

Upon successful completion of learning the Equipment/Sterile Operator II skills, the incumbent will receive an hourly rate increase and advance to the Equipment/Sterile Operator II role.

KEY ACCOUNTABILITIES

• Regular and predictable onsite attendance and punctuality.
• Ability to read filling schedule.

• Ability to read and follow applicable SOP’s and Work Instructions following training period
• Preparation of miscellaneous items, tubing, and filters reuqired by Filling or Compounding
• Use of cleaning equipment including but not limited to Crest Ultrasonic Washers, ultrasonic basins, Girton Washers, WFI point of use panels, thermometers, pressure gauges, etc.
• Demonstrated knowledge of proper documentation practices.
• Movement and loading of carts/trucks from autoclaves.
• Successful completion of gowning qualification and aseptic training.
• Ability to understand and use operational procedures for steam autoclaves and hot air oven.
• Demonstrated knowledge and understanding of proper load configurations, parameter sheets, interpreting of pressure and temperature charts, and associated documentation.
• P…