Quality Assurance Technician

TLDR

Perform routine inspections and testing of raw materials and final products to ensure compliance with regulatory standards in the biotechnology sector.

The Quality Assurance Technician is responsible for routine inspection and testing of raw materials and components as well as of final product for Cresilon’s products in the Animal and Human Health industries. This position requires a strong attention to detail as the individual will be responsible for identifying deviations in product quality or safety and ensuring compliance with local, state, and federal regulations, including current Good Manufacturing Practices (cGMP). Position is for 2nd shift.

Responsibilities:

  • Sample and perform visual inspection of final products and raw materials. Perform other testing under the direction of QA Operations Manager.
  • Perform line clearance activities and in-process inspections.
  • Monitor routine manufacturing operations for conformance to applicable procedures (see Gowning Qualification requirements below)
  • Transfer materials between facilities (see lifting requirements below)
    • Facility 1 of 2: 122 18th Street, Brooklyn, NY 11215
    • Facility 2 of 2: 87 35th Street, Suite 603/604/6R, Brooklyn, NY 11232
  • Operate testing equipment such as force testers, torque testers, and balances.
  • Report all deviations in product, components, raw materials, and equipment per their relevant procedures
  • Perform document control activities, including but not limited to printing logbooks and batch records.
  • Transcribe data into digital systems for tracking Quality Metrics.
  • Batch record review & support routine batch disposition

 

Requirements

Education: High School Diploma or Equivalent (2- or 4-year degree in Engineering, Science, or Technology/Biotechnology preferred)

  • Required experience in GMP and FDA regulated environments (ISO 13485:2016 preferred)
  • Ability to be Gowning Qualified per Cresilon’s SOP.
  • 1 year experience in regulated industry highly desirable
  • Ability to lift, walk, stand, reach, pull and push

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

The salary for this role is $25/Hour

Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. 

 

Benefits

Health Insurance

Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

MetroCard Reimbursement

Monthly MetroCard Reimbursement

Paid Time Off

Paid Vacation, Sick, & Holidays

Cresilon is a biotechnology company that develops and manufactures innovative hemostatic medical devices using proprietary hydrogel technology. Our products are designed to stop traumatic and surgical bleeding in seconds, targeting both human and veterinary applications, and are fundamentally changing emergency care standards.

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Salary
$25 per hour
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