Integra LifeSciences

  • Sterility Assurance Scientist

    Vacancy ID
    2018-28040
    Location
    US-MA-Mansfield
    Position Type
    Regular Full-Time
    Category
    Operations
  • Overview

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    Responsibilities

    • Maintains procedures and methodologies to cover sterilization programs
    • Gains and applies knowledge of FDA, ISO and EN sterilization and related microbiology standards and guidelines to all tasks
    • Supports technical assessments of contract sterilizers and laboratories
    • Ensures adequacy of contamination control measures at external suppliers
    • Provides training to procedural changes
    • Provides input on the resolution of sterility related non-conformances
    • Supports sterilization validations, cleaning validations, and supporting activities for all product families.
    • Works with product development to ensure timely and complete sterilization adoptions and validations of all new products.
    • Trains Product Development personnel in contamination control and sterilization requirements and procedures.
    • Collaborates with Subject Matter Experts from other departments (i.e. Design Quality Engineering) to ensure a comprehensive approach to bring new and changed product into production.
    • Assists in sterile release, bioburden and dose audit, and environmental monitoring programs as necessary
    • Creates and finalizes validation protocols and report ensuring they are lear, concise and compliant to work instructions and standards.
    • Knows and follows all laws and policies that apply to the position, and maintains the highest level of professionalism, ethics and compliance always.
    • Participate in audits and other compliance program-related activities.
    • Executes other duties/responsibilities as assigned by manager.

    Qualifications

    • A Bachelor Degree is required, preferably in Microbiology, Biological Sciences or Engineering
    • 1 – 3 years of experience in sterilization/microbiology, medical device, Pharmaceutical and or / food industry is required.
    • Working knowledge of ISO documents related to sterilization such as ISO 11135 and 11137. Familiar with government regulations and Industry guidelines for sterilization and microbiological control.
    • Working knowledge of Microsoft Office applications is required.
    • Ability to effectively work on cross-functional teams, interacting with a diversity of disciplines and locations, including international teams.
    • Experience writing standard operating procedures, protocols, and test reports is preferred.
    • Attention to detail. Excellent organizational and time management skills.
    • Must be able to work under pressure due to reporting deadlines.
    • Familiarity with basic quality tools and techniques.

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