Senior Sterility Assurance Scientist

Overview

The 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 processes
  
  

Physical 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