Overview
Sterility Assurance Specialist Jobs in Bloomington, Indiana, USA at Cook Medical
Cook Medical Sterility Assurance Specialist I Bloomington, Indiana
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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.
Develop knowledge in sterilization fields and stay current on industry changes or external concerns.
Support product development by performing product sterilization technical reviews/evaluations and adoptions.
Investigate and initiate technical activities leading to new or improved sterilization processes to meet strategic goals and objectives.
Provide mentorship, training, and support to Cook Inc. departments.
Perform and approve cycle/product reviews and requalifications.
Perform and approve routine sterilization load release.
Build 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.
Interact effectively and professionally with various levels of the global organization.
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.
Prepare reports, publish, and make presentations to communicate findings and updates.
Qualifications:
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.).
Physical Requirements:
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.
Requisition :
Posting Date: 2 days ago (1/24/2025 9:01 AM)
Job Location(s):
Bloomington, IN, United States
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Title: Sterility Assurance Specialist
Company: Cook Medical
Location: Bloomington, Indiana, USA
Category: Healthcare, Quality Assurance – QA/QC
