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Quality Assurance Specialist

2 weeks ago


Brooklyn, New York, United States Cresilon, Inc. Full time

Cresilon, Inc. is a Brooklyn-based biotech company pioneering the development, manufacturing, and marketing of hemostatic medical devices leveraging its patented hydrogel technology.

Job Overview

We are looking for a seasoned Quality Assurance Specialist - Analytical Chemistry to join our team as a Subject Matter Expert (SME) in Current Good Manufacturing Practices (cGMP) analytical chemistry. The successful candidate will work collaboratively with FDA and other 3rd Party testing facilities to ensure compliance with applicable regulations.

  • Key Responsibilities:
  • Validate analytical methods and qualify instrumentation to meet regulatory requirements.
  • Establish and maintain cGMP-compliant analytical procedures, protocols, and reports.
  • Mentor and train staff on cGMP analytical chemistry expectations.
  • Collaborate with internal stakeholders and external partners to drive project success.
  • Manage external testing activities as needed.

Requirements:

A Bachelor's degree in chemistry, biochemistry, or a related life-science discipline is mandatory. A Master's or Doctorate in analytical chemistry is desirable.

Preferred Qualifications:

  • 7+ years of experience in medical device/pharmaceutical analytical chemistry quality control.
  • 4+ years of analytical chemistry method validation.
  • 4+ years of analytical chemistry method development.
  • Experience with FDA submissions and clearance on device/product.

Benefits:

  • Paid Vacation, Sick, & Holidays.
  • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage.
  • Company Paid Life and Short-Term Disability Coverage.
  • Work/Life Employee Assistance Program.
  • 401(k) & Roth Retirement Savings Plan with company match up to 5%.
  • Monthly MetroCard Reimbursement.