Quality Control Technologist

Overview

Werfen

 

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.  We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

 

 

We are looking to hire an experienced Quality Control Technologist to work in our NJ Office.  As a part of our Quality Control team, this position is responsible for performing laboratory and chemical testing.  If you enjoy working in a team environment, and thrive on challenges, we want to hear from you. Apply today!

 

This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time.

 

Quality Control Technologist

 

Responsibilities

 

Perform incoming, in-process, and final release testing, along with document review in the Quality Contorl GMP laboratory.

Key Accountabilities

• Performs incoming raw material, in-process, final testing and inspection of products according to approved Standard Operating Procedures (SOP’s) within defined timeframes.
• Test methods/equpment used include: PCR, gel electrophoresis, and DNA extraction.
• Analyze data using product software. Master the use of BASIS and NGS applications for data analysis.
• Maintains accurate, legible, and complete records according to Current Good Manufacturing Procedures (cGMP’s).
• Performs all assigned tasks following applicable laboratory SOPs, OSHA regulations and cGMP regulations (i.e. Blood borne pathogens and chemical hazards).
• Maintains work area, equipment, department, and all storage areas in a clean, neat, and orderly manner.
• Reports out-of-specification results and deviations to the department supervisor and/or manager.
• Assists with investigations, root cause analyses, and reports for out-of-specification results and deviations.
• Monitors supply inventory and identifies any products required.
• Assists department supervisor and manager in maintaining and compiling Device History Records.
• Perform equipment calibration, cleaning, and maintenance.
• Overtime may be required which may include holidays and weekends
• Ability to follow regualtions, including: ISO 13485, 21 CFR Part 820, and other medical device regulations.
• Performs other duties and responsibilities as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Quality Control Technologist

 

Qualifications

Education: Bachelor’s degree in a science related field required. (EX. Biology, chemisty, Biomedical).

 

Experience: Minimum 1 year laboratoy experience required (This can include Univeristy lab experience).  Preferred one or more years of experience in a GMP commerical laboratory (pharmacuetical or medical device industry.)

 

Desired:  Experience using manual and automated pipettes to dispense volumes of 0.1 ul through 5 mL.

 

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• • Pipetting solutions of varying volumes.
  • Performing DNA extraction.
  • Running a thermocyclcer.
  • Performing gel electrophoresis.

 

Quality Control Technologist

 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day.  Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment.  May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch.  Will be required to talk and hear and have specific vision abilities, including c