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Sterilization Operations Technician 1
4 months ago
**Date**:May 7, 2024
**Location**: Pendleton, SC, US, 29670
**Company**:Arthrex
**Requisition ID**:
- 60241**Title**:
- Sterilization Operations Tech I - SC (AMIX)**Division**:
- Arthrex Manufacturing Inc (US02)**Location**:
- Pendleton, SC- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for Level I Sterilization Operations Technicians for our Pendleton, SC facility. The individual in this position will be responsible for the safe, efficient and timely sterilization processing and handling of medical products. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better._
**Main Objective**:
Under the direction of the Operations Manager and Supervisor - Sterilization Operations, the operations tech will be responsible for the safe, efficient and timely X-Ray and E-Beam sterilization processing and handling of medical products according to AMI SOPs, specifications and established policies with mínimal direct supervision.
**Essential Duties and Responsibilities**:
- Responsible for following all Good manufacturing Practices and SOP’s as defined by AMI procedures and policies to ensure that FDA, ISO and AMI quality standards are met.
- Understand and strictly adhere to all established safety, health and environmental procedures.
- Maintain AMI shipping and receiving areas to ensure efficient processing of loads.
- Receive, log, examine for damage on all incoming product and place/verify presence of sterility test samples as required. Ensure that all products are clearly identified per the appropriate work instructions.
- Load product on the conveyor as required by process cycle specifications (PCS).
- Start computerized sterilization cycles according to AMIX specifications to ensure validated sterilization processing. Review sterilization records to ensure adequate compliance to the requirements for each specific load.
- Place and retrieve dosimeters, place and retrieve samples if applicable, repalletize the product, placard the status and wrap the pallet.
- Responsible for the immediate reporting of safety, quality, or any other operational deficiencies.
- Remove samples from loads and deliver to designated labs for testing. Ensure that testing requirements are clearly documented in papers with sample shipment. Set up shipping AMI requirements via standard carriers.
- Document processing conditions and verify that they meet AMI processing specification requirements. Maintain proper product labeling and segregation through all stages of the sterilization process.
- Responsible for safe sterilizer operation, safe forklift operation, safe irradiation facility practices, and proper use of all personal protective equipment.
- Responsible for monitoring the facility radiation levels and equipment operating alarm conditions to ensure safe and proper operation of facility and equipment.
- Participate in communication meetings, process improvement projects, lean/sigma projects to establish best demonstrated practices for continuous improvement efforts throughout the operation.
- Work in and around the Rhodotron accelerator and dosimetry system.
**Education and Experience**:
- High School diploma or equivalent required; Bachelor’s degree in Science related discipline preferred
- 2 years manufacturing experience required
- Experience in sterilization preferred
- Experience in a Good Manufacturing Process regulated industry a plus
**Incidental Duties**:
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
**Knowledge and Skill Requirements/Specialized Courses and/or Training**:
Ability to work at a desk, in an office area, or in a light manufacturing area. Computer skills including Microsoft products and data entry, data acquisition and process operation software. Knowledge of and ability to implement FDA QSR requirements. Experience with process safety including hazard communication, electrical safety and chemical handling safety procedures.
Sterilization Operation Techs will be required to participate in a radiation safety course and pass a written exam.
**Reasoning Ability**:
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
**Mathematical Skills**
**Language and Communication Skills**:
**Physical Demands**:
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.
- While performing this job the employee is regularly required to talk or hear. The employee is fre
