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Quality Assurance Associate

Cresilon, Inc.
New York, NY
  • Posted: over a month ago
  • Full-Time
Job Description

Cresilon, Inc is a medical device company based out of Brooklyn, NY that focuses on bringing new technologies to the animal health industry that aim to solve problems associated with wound healing. We have created a hemostatic device that can instantly stop traumatic bleeding. Please refer to these associated links to learn more about Cresilon:

  1. https://www.bloomberg.com/news/videos/2014-11-19/bandaid-of-the-future-stops-bleeding-instantly
  2. http://www.ted.com/talks/joe_landolina_this_gel_can_make_you_stop_bleeding_instantly?language=en


The Quality Assurance associate is responsible for routine inspection and testing of raw materials and components as well as of final product for Cresilons 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).

Ongoing Responsibilities

  • Sample and perform visual inspection of final products and raw materials. Perform other testing under 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
  • Related duties as assigned.

Requirements

Requirements:

  • High School Diploma or Equivalent (2- or 4-year degree in Engineering, Science, or Technology/Biotechnology preferred)
  • Experience Required Experience in GMP and FDA regulated environments (ISO 13485:2016preferred)

Proficiency:

  • Ability to be Gowning Qualified per Cresilons SOP.
  • Ability to read, understand, and execute written work instructions.
  • Ability to complete cGMP documentation per Cresilons SOP.
  • Ability to perform basic arithmetic using all units of measure.
  • Ability to communicate verbally and in writing in English.
  • Microsoft Office (Word, Excel, Outlook).
General
  • Ability to lift at least 40 pounds of force occasionally and to lift, carry, push, pull, and/or otherwise move objects.
  • Ability to walk 1-3 miles and stand for 3-6 hours during a shift, as required.
  • Ability to work any shift (1st, 2nd, or 3rd) and any day of the week (7 days), as required.
  • Ability to climb, balance, stoop, reach, stand, and walk.
  • Ability to bend, twist, push, lift, and grasp.
  • Ability to perform repetitive motions, including substantial movement of wrists, hands, and or fingers.

Benefits

  • Paid Vacation and Holidays, including a minimum of 25 vacation days
  • Sick days; personal time
  • 100% Employer-covered Medical, Dental, and Vision Insurance
  • Firm Paid Life and Short-Term Disability Coverage
  • 401(k) Retirement Savings Plan and 5% Employer match
  • Stock options

Cresilon, Inc.

Address

New York, NY
USA

Industry

Technology

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