Quality Assurance Associate Jobs

Cresilon, Inc is a medical device company based out of Brooklyn, NY. Our mission is to save lives. We focus on bringing new technologies to animal and human health to solve problems associated with wound healing. We have created a hemostatic technology that can instantly stop traumatic bleeding. Please refer to these associated links to learn more about us:

• Http://www.ted.com/talks/joe_landolina_this_gel_can_make_you_stop_bleeding_instantly?language=en
• Https://www.bloomberg.com/news/videos/2014-11-19/bandaid-of-the-future-stops-bleeding-instantly

The Quality Assurance Associate 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).

RESPONSIBILITIES:

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

QUALIFICATIONS:

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

Requirements

QUALIFICATIONS:

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

At Cresilon, Inc. we value diversity and inclusivity. We are an equal-opportunity employer and we do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Benefits

Medical, Dental, Vision, 401K Paid Time Off, Holiday pay