What are the responsibilities and job description for the Quality Control Technologist - NJ position at Werfen?
Overview
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 – Medical Technologist
Responsibilities
As a Quality Control Technologist, you will perform all assigned tasks following applicable laboratory SOPs, OSHA regulations and cGMP regulations (i.e. blood-borne pathogens and chemical hazards) and any other applicable regulations. You will report out-of-specification results and deviations to the department supervisor and/or manage as well as assist with investigations, root cause analysis, and reports for out-of-specification results and deviations. Your will also be responsible for maintaining and compiling Device History Records. Overtime may be required which may include holidays and weekends.
- Performs incoming raw material, in-process, final testing and inspection of products according to approved Standard Operating Procedures (SOP’s) within defined timeframes.
- Performs stability and other special testing.
- Performs method validations and equipment validations.
- Performs threshold analysis process.
- Writes/Revises SOPs, WI, QCS documents.
- 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.
- Mastering the use of BASIS application for data analysis.
- Monitoring QC lab cleaning.
- Review and trend Enviromental Monitoring results.
- Conducts themselves in a polite, helpful, and professional manner with all employees both inside and outside of the department.
- Assists with special projects and other duties as assigned
- Performs incoming raw material, in-process, final testing and inspection of products according to approved Standard Operating Procedures (SOP’s) within defined timeframes.
- Performs stability and other special testing.
- Performs method validations and equipment validations.
- Performs threshold analysis process.
- Writes/Revises SOPs, WI, QCS documents.
- 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.
- Mastering the use of BASIS application for data analysis.
- Monitoring QC lab cleaning.
- Review and trend Enviromental Monitoring results.
- Conducts themselves in a polite, helpful, and professional manner with all employees both inside and outside of the department.
- Assists with special projects and other duties as assigned
Quality Control Technologist – Medical Technologist
Qualifications
Qualified candidates for Quality Control Technologist II have at least a year of related experience and at least one years’ experience in Blood Banking/Transfusion Medicine. We are looking for a professional, self-motivated individual with exceptional communication and strong analytical skills.
Additional Quality Control Technologist requirements include:
- Bachelor’s Degree in Medical Technology, Life Sciences or other sciences or technical field
- Experience operating and maintaining Illumina sequencers analyzing NGS data a plus
- Experience with various DNA and RNA extractions methods is preferred
- Software experience: Excel, Word, and Power Point
- Critical thinker who can analyze data and provide summary analysis to management.
- Ability to manage and complete assignments on time and in appropriate order.
- Capability of working with multiple departments to achieve department and site objectives.
- Ability to work independently with minimal supervision.
- Strong organizational skills
- Engaged and committed team professional
- Independent thinker and self-learner
- Collaborates effectively with others
Quality Control Technologist – Medical Technologist
