What are the responsibilities and job description for the Sterility Assurance Specialist I position at Cook Medical?
Overview
The Sterility Assurance Specialist I at Cook Incorporated is responsible for multiple projects/tasks related to ensuring continued compliance with sterilization validation and product adoption requirements. The Sterility Assurance Specialist will collaborate on cross-functional teams to perform necessary tasks relating to product/process change evaluations, sterilization validations, product adoption, and assurance of sterility requirements.
Responsibilities
The Sterility Assurance Specialist I at Cook Incorporated is responsible for multiple projects/tasks related to ensuring continued compliance with sterilization validation and product adoption requirements. The Sterility Assurance Specialist will collaborate on cross-functional teams to perform necessary tasks relating to product/process change evaluations, sterilization validations, product adoption, and assurance of sterility requirements.
Responsibilities
- Collaborate and approve product/process changes to ensure sterilization validation remains compliant. Request testing as needed
- Develops knowledge in sterilization fields and stays current on industry changes or external concerns
- Support product development by performing product sterilization technical reviews/evaluations and adoptions
- Investigates and initiates technical activities leading to new or improved sterilization processes to meet strategic goals and objectives
- Provides mentor-ship, training and support to Cook Inc. departments
- Performs and approves cycle/product reviews and requalifications
- Performs and approves routine sterilization load release
- Builds Process Challenge Devices, dunnage loads, and other duties assigned
- Support microbiology testing and/or projects
- Work closely with other functions to define projects and objectives when applicable
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization
- Must strictly adhere to safety requirements
- Maintain regular and punctual attendance
- Drive and direct continued improvement of Sterility Assurance operations
- Maintain company quality and quantity standards
- Must have effective oral and written communication skills
- Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
- Ability to remain calm and receptive in fast paced situations
- Prepares reports, publishes, and makes presentations to communicate findings and updates
- Bachelor's degree in Engineering, Microbiology, Biology, or related field.
- Desired minimum of 1-2 years medical device or pharmaceutical experience
- A history of high performance demonstrating proficiency in several of the above listed job functions/duties preferred
- Dependent upon demonstrated proficiency, significantly skilled individuals lacking in the minimum length of experience or education listed
- Proficient in computer skills (excel, word, etc)
- Occasional travel may be required
- Must be able to perform reasonable job functions requiring periods of sitting, standing, walking, as well as those requiring manual dexterity, effective listening and communication
- Must be able to perform essential job functions
- Works under general office environmental conditions
- Personal protective equipment including safety glasses, lab coat and gloves required in certain areas associated with this position
