QA Specialist I Thermo Fisher Scientific Millersburg

Short Description :

Implement procedures Develop and write protocols and new procedures Excellent technical skills 1+ years of ,…

Full Description :

Job Title : QA Specialist I
Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brandsLife Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Servicesoffer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit .
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 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

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 process 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 , 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.

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