Immucor, Inc. Quality Control Technologist III in Warren, New Jersey
Founded in 1982 and based in Norcross, GA, Immucor is a global leader in transfusion and transplantation diagnostics that facilitate patient/donor compatibility worldwide. Our mission is to ensure that patients in need of blood, organs, or stem cells get the right match that is safe, accessible, and affordable. The result is life changing for a patient in need of a transfusion or transplant. Our new corporate identity illustrates the right match of donors with patients in need of blood or an organ as well as Immucor’s partnership with healthcare organizations in need of innovation and productivity. With the right match, we can transform a life together!
If you’re a QC expert with lab experience, Immucor has an exciting opportunity for you! We are looking to hire a Quality Control Technologist with GMP QC lab testing medical device, and/or the pharmaceutical production experience. This critical role will lead QC projects, perform Incoming, In-process, final release and stability testing in the Quality Control Laboratory. They will serve as Team Lead in the QC lab to assist supervisor and Director in daily operations of the Quality Control Laboratory and provide guidance to the QC staff.
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 .
*Provides direction and guidance to Quality Control staff in the performance of daily tasks.
Completes and approves daily and weekly scheduling of all QC related activities
Performs and schedules incoming raw material, in-process, final testing and inspection of Bio Array products according to approved Standard Operating Procedures (SOP’s) and other applicable documents within defined time-frames.
*Act as OJT trainer to train new employees and current employees on new test methods
*Guides QC technicians training activities and ensures that the appropriate training records are completed as per the role functions
Performs and schedules stability, method validations, equipment validations, threshold analysis process and other special testing.
Coordinates and delegates the maintenance of lab supply inventory, and guides the maintaining, final reviewing and final approving and compiling Device History Records.
Writes/Revises/Approves 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 and escalates out-of-specification results and deviations to the department supervisor and/or manager.
Assists and leads with investigations, root cause analyses, and reports for out-of-specification results and deviations.
Monitors stability testing time points, ensures samples are pulled and tested at the correct intervals, and performs data analysis to support QA/QC management
Monitors, together with Operations/ MFG, the supply inventory to identify any products required
Performs, schedules and delegates equipment calibration and maintenance
Mastering the use of BASIS and NGS application for data analysis.
Supports scheduling of the QC lab cleaning with Facilities
Review and trend Environmental Monitoring results
Maintaining and compiling of Device History Records
Leads all QC related activities and represents QC team in cross functional meetings
**Bachelor’s degree (BS/BA) from four-year college or universitybiology, chemistry, etc; or equivalent combination of education and experience
*Working knowledge of 21 CFR820, ISO 13485, IVDR is required
*Minimum of two-three years experience in QC or other equivalent work experience
*Previous medical device and/or IVD experience required
*2-3 years of FDA/GMP experience a plus
*Proficient in MS Office
*Problem solving abilities
Quality Control Technologist III
IMMUCOR, INC IS AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER; MINORITY/FEMALE/DISABILITY/VETS; DRUG FREE WORKPLACE
RESUMES SUBMITTED TO IMMUCOR FROM THIRD PARTY RECRUITMENT FIRMS WILL NOT BE CONSIDERED.
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.
Immucor offers a comprehensive benefits package available on the start date of your employment, including:
Medical, prescription, dental, and vision insurance – we offer multiple plan options so you can determine which best suits your needs and the needs of your dependents
STD/LTD/Life insurance all 100% company paid
Voluntary life/accident/hospital indemnity insurance for yourself, spouse/domestic partner and dependents
Company matched 401k plan
Vacation/Company & Personal Holidays/Sick days
Were permitted by applicable law, all Immucor new hires must be fully vaccinated against COVID or have an approved Immucor exemption. Proof of vaccination status will be required no later than first day of employmen t.
Job Locations US-NJ-Warren
Job ID 2022-3107