Lead Quality Assurance Chemist

1 week ago


Brooklyn, New York, United States Cresilon, Inc. Full time
Cresilon, Inc.: Expert in Analytical Chemistry

Cresilon, Inc., a pioneering biotechnology firm, is on the lookout for an Expert in Analytical Chemistry to enhance their dynamic team. The organization is dedicated to creating groundbreaking hemostatic medical devices utilizing plant-derived hydrogel technology aimed at swiftly controlling bleeding in both traumatic and surgical scenarios. As a vital contributor, you will play a key role in the validation of analytical methodologies, qualification of instrumentation, and ensuring adherence to regulatory compliance.

Key Responsibilities
  • Act as the organization's Subject Matter Expert (SME) in current Good Manufacturing Practices (cGMP) related to analytical chemistry
  • Engage collaboratively with regulatory bodies and external testing laboratories
  • Oversee the validation of analytical methods and the qualification of laboratory instruments
  • Generate and critically assess cGMP data
  • Conduct routine analytical evaluations
  • Provide mentorship to team members regarding analytical chemistry standards
  • Work collaboratively across departments to support laboratory functions
  • Coordinate external testing as required
Qualifications
  • Bachelor's degree in chemistry, biochemistry, or a closely related discipline
  • A minimum of 7 years of experience in analytical chemistry within the medical device sector
  • Familiarity with FDA submission processes and regulatory clearances
  • Expertise in United States Pharmacopeia (USP) validation and instrument qualification
  • Understanding of Quality Management System (QMS) audits and laboratory information management systems
Employee Benefits
  • Comprehensive paid time off, along with medical, dental, and vision coverage
  • Retirement savings plan featuring company contributions
  • Access to an employee assistance program and additional benefits

Cresilon, Inc. is committed to fostering an inclusive workplace that values diversity. Join us in our mission to innovate and save lives through advanced technology.



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