[ref. g68429116] Warren - Quality Control Technologist III-Stability
Overview:
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 when it comes to manufacturing, Immucor has an exciting opportunity for you! We are looking to hire a Quality Control Technologist III medical device, and/or the pharmaceutical industry. This critical role will Lead QC stability projects, perform Incoming, In-process, final release and stability testing in the Quality Control Laboratory.Act 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.
Responsibilities:
Job Summary
This role will be the team SME (subject matter expert) on product stability. This will include writing stability protocols and reports, performing product testing, and trending stability data.
They may lead QC projects, perform Incoming, In-process, final release, and stability testing in the Quality Control Laboratory. They will be a Team Lead in the QC lab to assist the supervisor/ manger and Director in daily operations of the Quality Control Laboratory and provide guidance to the QC staff.
Key Accountabilities- Monitors stability testing time points, ensures samples are pulled and tested at the correct intervals, and performs data analysis to support QA/QC management. Drafts stability protocols and reports. Performs trend analysis onstability data throughout the stabiity protocol timeline. Develops timeline for annual stability and determines which products are required.
- Provides direction and guidance to Quality Control staff in the performance of daily tasks. Creates daily and weekly scheduling of all QC related activities
- Performs and schedules testing for incoming raw material, in-process, final release and inspection of BioArray products according to approved Standard Operating Procedures (SOP’s) and other applicable documents within defined timeframes. Performs and schedules stability, method validations, equipment validations, threshold analysis process and other special testing.
- 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
- Reports and escalates out-of-specification results and deviations to the department supervisor/manager. Assists and leads the investigations, root cause analyses, and reports for out-of-specification results and deviations.
- Writes/Revises SOPs, WI, QC Specification/testing 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. Performs, schedules and delegates equipment calibration and manintenance.
Qualifications:
Ba sBachelor’s degree in biology or chemistry or related field. Four (4) or more years experience in a medical device or pharmaceutical GMP quality laboratory. Experience working under 21 CFR Part 210/211 and/or 820 regulations required. Knowledge of ISO 13485 desired.
Two (2) or more years of experience performing stability testing required. Experience writing stability protocols, performing data trending, and writing stability reports preferred.
Eperience performing OOS Phase I investigations, in alignment with FDA guidelines, required.
Expereince training QC technicians desired.
Expereience performing PCR (Polymerase chain reaction) desired.
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Quality Control Technologist III-Stability
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
- Wellness program
- STD/LTD/Life insurance all 100% company paid
- Voluntary life/accident/hospital indemnity insurance for yourself, spouse/domestic partner and dependents
- Tuition reimbursement
- 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 to be considered for US - based jobs. If not currently employed by Immucor, Inc. proof of vaccination status will be required no later than first day of employment.