Quality Assurance Technician
Cresilon, Inc.
Summary
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.
Job description
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
Requirements
- 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
- Paid Sick Leave
- Paid Holidays
- Medical, Dental & Vision
- FSA Dependent & Healthcare
- Commuter & Parking Benefits
- Long Term Disability
- Company Paid Life Insurance
- Short-Term Disability Coverage
- Employee Assistance Program
- 401(k) & Roth Retirement
- Company Match up to 5%
- Monthly MetroCard Reimbursement
Company overview
Cresilon, Inc. is a Brooklyn-based biotechnology company specializing in revolutionary hemostatic medical device technologies. Founded in 2010 by CEO Joe Landolina, the company develops, manufactures, and markets proprietary hydrogel-based products that stop traumatic and surgical bleeding in seconds without requiring manual pressure. Cresilon's plant-based technology represents a significant advancement in wound care, utilizing algal-based polymers to create instant hemostatic gels. The company's product portfolio includes VETIGEL® for veterinary applications and TRAUMAGEL® for human trauma and emergency care, both of which have received FDA clearance. With a mission to save lives, Cresilon has secured over $63.9 million in funding and employs 51-200 professionals focused on advancing hemorrhage control technologies for both animal and human health markets. The company has been recognized with prestigious awards including a Gold Stevie Award for Most Innovative Company of the Year.