Sorry, this listing is no longer accepting applications. Don’t worry, we have more awesome opportunities and internships for you.

QA Specialist I

Thermo Fisher Scientific

Thermo Fisher Scientific

QA Specialist I

Millersburg, PA
Full Time
Paid
  • Responsibilities

    Key Responsibilities:

    • Collect and enumerate EM samples both viable and non-viable sample locations within the MBG site as prescribed by the MBG EM program.
    • Collect, analyze and present EM or relevant quality data.
    • Establish and optimize test methods and specifications.
    • Analyze the adequacy of EM criteria and techniques, recognize process trends and take appropriate action (investigation/escalation).
    • Develop and write protocols and new procedures.
    • Review and edit existing procedures.
    • Work with Product Development/Engineering to implement new processes and products.
    • ECO Approvals
    • PPI / Tier Board Coordinator/Communication
    • CAPA, Trackwise, and Customer Compliant support.
    • Support Internal Audits
    • Day to Day tasks as assigned
  • Qualifications

    Minimum Qualifications:

    • Bachelor's degree. Biology or Microbiology preferred, or relevant work experience.
    • Strong working knowledge of FDA Quality Systems Regulations (21CFR820) and International Quality System Standards (ISO13485).
    • Ability to understand various manufacturing processes.
    • Excellent writing and communication skills.
    • Ability to interface well with others working at all levels.
    • Ability to develop and implement procedures.
    • Ability to perform investigative processes as well as critical thinking and problem-solving.
    • Knowledge of windows and statistical-based computer programs such as Excel, Minitab, and well as Microsoft Office.
    • Ability to read and understand CAD drawings.

    Preferred Qualifications:

    • 1+ years of quality or engineering experience.
    • Ability to understand various manufacturing processes.
    • Excellent technical skills.
    • Ability to travel both domestic and some foreign.

    At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

  • Industry
    Biotechnology
  • Fun Fact
    25% of our current revenue is generated from products that didn’t exist 5 years ago.
  • About Us

    As the world’s leader in serving science, Thermo Fisher Scientific's professionals develop critical solutions—and build rewarding careers. They help customers in finding cures for cancer, protecting the environment, making sure food is safe, and so much more. When you #StartYourStory with Thermo Fisher, you are guaranteed meaningful work - both personally and professionally.