What are the responsibilities and job description for the Senior Sterility Assurance Scientist position at Cook Medical?
OverviewThe Senior Sterility Assurance Scientist will be responsible for working on multiple initiatives in support of various business / technical objectives in terminal sterilization with respect to Sterilization and microbiological aspects. This position will be a key contact to individual operating companies / business units as a Subject Matter Expert (SME) for microbiological and sterilization areas.Responsibilities
- Interface with cross-functional groups (Quality Assurance, Regulatory Affairs, Operations and Manufacturing and serve as the subject matter expert to address and resolve sterilization related inquiries and technical issues (materials and / or processes) from regulatory bodies / agencies.
- Work with Operations and individual companies / business units on sterilization validation / re-qualification requirements and the generation of appropriate test methods to meet Quality and Regulatory objectives.
- Development of test methods, protocols and finished summary reports in relation to sterilization validations in compliance with the appropriate AAMI / ISO sterilization standards.
- Coordination of signature approvals to include the appropriate personnel when generating protocols and finished summary reports.
- Evaluate medical devices to determine the worst-case location for sterilization within the product and determine the best method for inoculation with appropriate spore strip / string / suspension.
- Perform product / packaging evaluations on new and / or modified product to determine appropriate sterilization method and determine testing required.
- Investigate, document, and determine corrective action for sterilization deficiencies.
- Perform microbiological laboratory processes / testing required as part of the sterilization validations / re-qualification protocols.
- Understand and conform to Corporate and Quality standards such as : Quality System Regulation (QSR), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP).
- Work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Self-starting, results oriented individual with demonstrated ability to work in a team while also being productive independently.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
- 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.
- Must maintain company quality and quantity standards.
- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.
- Ability to remain calm and receptive in fast paced situations.Qualifications
- BA / BS or MA / MS degree in Chemistry, Biology, Engineering, or other scientific discipline required
- A minimum of 3 years medical device sterilization validation experience or experience of such kind and amount as to provide comparable background
- Expertise in areas of microbiology, Gamma, Steam, Dry Heat, EO, and other sterilization methodologies
- Strong knowledge in quality systems and QA compliance as it relates to the sterilization process and new product introduction
- A strong background with hands on experience in terminal sterilization validation and microbiological laboratory processesPhysical Requirements :
- Works under general office environmental conditions
- Utilizes close visual acuity for working with computers and equipment
- Frequently required to sit, stand, walk, and communicate
- Personal protective equipment including safety glasses, lab coat and gloves required in certain areas associated with this position
- 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 Learn More
