Biological Safety Expert

3 weeks ago


Hopkins, Minnesota, United States Medica USA Full time
Job Details

This is a senior-level role that requires expertise in laboratory testing and quality assurance. The ideal candidate will have a strong understanding of ISO and FDA regulations and experience working in a fast-paced environment.

Key Responsibilities:
  • Perform testing and review results.
  • Demonstrate laboratory troubleshooting skills and critical thinking.
  • Equipment maintenance & daily QC.
  • Prepares test orders and specimens for testing and/or transfer to reference laboratory.
  • Performs inspections/testing and quality release (raw materials, in-process, and product release) in a clean room environment.
  • Assist in writing or reviewing newly written or revised validation plans, test methods, and/or procedures as applicable to the lab and review the completed validations for accuracy and completeness.
  • Maintain laboratory areas and equipment in a safe, functional and sanitary condition.
  • Report any actual or potential deviation from standard or accepted testing procedures and cooperate fully with any investigation of same.
  • Supports audits as required.
Requirements:
  • Associates Degree or Bachelor's degree.
  • 3-5 years of experience in medical devices and manufacturing.
  • Exposure to ISO and FDA regulations.
  • Self-directed with excellent attention to detail.
  • A strong knowledge of basic mathematical operations is desirable.
  • Demonstrated verbal and written communication skills.
  • Demonstrated computer skills and a working knowledge of computer software (MS Outlook, MS Word, and Excel).
  • Must have the ability to work in a fast-paced environment with an attention to detail, organization, and time management skills are required.

Estimated Salary: $100,000 - $130,000 per year.



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