Temporary Sterilization Operations Tech I
Arthrex Manufacturing Inc
Ave Maria FL
Arthrex is searching for a Temporary Sterilizations Operations Technician to work at the Ave Maria, FL facility. This position will work a rotating, second shift schedule from 7pm to 7am including weekends. Training will take place during dayshift hours.
Under the direction of the Operations Manager and Process Supervisor, responsible for the safe, efficient and timely EtO sterilization processing and handling of medical products according to AMI SOPs, specifications and established policies with minimal 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 and place/verify presence of sterility test samples on all incoming product. Ensure that all products are clearly identified.
- Load product into preconditioning, sterilizer and aeration as required by process cycle specifications (PCS). Monitor area conditions to ensure proper processing conditions are maintained.
- Start computerized sterilization cycles according to vendor specifications to ensure validated sterilization processing. Review sterilization records to ensure adequate compliance with internal and external requirements for specific loads.
- Upon completion of chamber processing, unload product to the aeration areas. Monitor aeration conditions to ensure proper processing conditions are maintained.
- 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 EtO handling practices, and proper use of all personal protective equipment including respirators while performing designated tasks.
- Responsible for monitoring facility air quality and equipment operating alarm conditions to ensure safe and proper operation of facility and equipment.
- Participate in monthly communication meetings, process improvement projects, lean/sigma projects to establish best demonstrated practices for continuous improvement efforts throughout the operation.
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.
Education and Experience:
- High School diploma or equivalent required.
- Bachelor's degree in Science related discipline OR 3 years' experience in the field of sterilization operations is preferred.
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 including clean room.
- Extensive computer skills including Microsoft products and data entry, data acquisition and process operation software.
- Knowledge of and ability to implement FDA QSR requirements.
- Extensive experience with process safety including hazardous communication, respiratory safety, electrical safety and chemical handling safety procedures.
- 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.
- Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
Language and Communication Skills:
- Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.
- Ability to verbally communicate ideas and issues effectively to other team members and management.
- Ability to write and record data and information as required by procedures.
- 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 frequently required to sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The position may require prolonged walking and standing, awkward postures, working at heights and in hot or cold conditions. The employee must occasionally lift and/or move up to 10 pounds. Must maintain medical qualification to wear prescribed respiratory protection and other personal protective equipment for extended times.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Visual acuity necessary to do the job safely and effectively.
- Specific vision abilities required by this job include close vision.
- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock. The noise level in the work environment is usually moderate.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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