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Senior Quality Assurance Chemist

2 months ago

New York, New York, United States Cresilon, Inc. Full time
Cresilon, Inc. Seeks Analytical Chemistry Expert

Cresilon, a biotechnology company, is seeking an Analytical Chemistry Expert to join their team. The company focuses on developing innovative hemostatic medical devices using plant-based hydrogel technology to quickly stop bleeds in traumatic and surgical situations.

Key Responsibilities
  • Ensure analytical methods are validated and compliant with regulatory requirements.
  • Collaborate with FDA and third-party testing facilities to ensure compliance.
  • Validate analytical methods and qualify instrumentation to ensure accuracy and reliability.
  • Generate and review cGMP data to ensure compliance and accuracy.
  • Execute routine analytical testing to ensure quality and compliance.
  • Mentor staff on analytical chemistry expectations and best practices.
  • Collaborate cross-functionally with laboratory operations to ensure seamless execution.
  • Manage external testing as needed to ensure compliance and accuracy.
Requirements
  • Bachelor's degree in chemistry, biochemistry, or related field.
  • 7+ years of experience in medical device analytical chemistry.
  • Experience with FDA submissions and clearance.
  • Proficiency in USP validation and instrument qualification.
  • Knowledge of QMS audits and laboratory information systems.
Benefits
  • Paid time off, medical, dental, and vision insurance.
  • Retirement savings plan with company match.
  • Employee assistance program and more.

Cresilon, Inc. is an equal opportunity employer dedicated to diversity and inclusion.