Quality Control Technologist -Transfusion

Werfen•Warren Township, NJ

6d•Onsite

About The Position

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. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Job Summary Perform incoming, in-process, and final release testing, along with document review in the Quality Control commercial GMP laboratory.

Requirements

Bachelor’s degree in a science related field required. (EX. Biology, chemisty, Biomedical).
Minimum 1 year laboratoy experience required (This can include Univeristy lab experience).
Pipetting solutions of varying volumes.
Performing DNA extraction.
Running a thermocyclcer.
Performing gel electrophoresis.

Nice To Haves

Preferred one or more years of experience in a GMP commerical laboratory (pharmacuetical or medical device industry.)
Experience using manual and automated pipettes to dispense volumes of 0.1 ul through 10 mL.
Experience performing polymerase chain reaction (PCR)

Responsibilities

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/equipment 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) and ALCOA data integrity requirements.
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 regulations, 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.