(USA-GA-Norcross) BQA Technical Specialist

**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. We are looking for a Biological Quality Assurance (BQA) Technician III to join our QA team. The Biological Quality Assurance Technician III is responsible for Performing a variety of tasks and functions associated with the appropriate day-to-day operations of the Technical Specialist division within the Quality Laboratories. Works to achieve compliance ready state of each laboratory area. This includes but not limited to the coordination of training, new and incumbent employees on equipment, documentation, product control, product handling, storage, environmental monitoring and any other task associated with making sure the products reach the customers. Also, will assist with review and approving of test data, trending environmental monitoring data, writing, reviewing and creating SOPs and OJTs. Overseeing and assisting with special projects 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_ . **Biological Quality Assurance Technical Specialist – QA - Healthcare** **Responsibilities** As the Biological Quality Assurance Technician III, you ensure strong GMP environment within a very dynamic and changing manufacturing/quality environment. Achieve compliance ready state of each laboratory area. This includes but not limited to the coordination of training, new and incumbent employees on equipment, documentation, product control, product handling, storage, environmental monitoring and any other task associated with making sure the products reach the customers. Also,will assist with review and approving of test data, trending environmental monitoring data, writing, reviewing and creating SOPs and OJTs. Overseeing and assisting with special projects Additional responsibilities of the Biological Quality Assurance Technician III include: + Reviews data generated by the BQA Department. + Ensures all department employees follow applicable laboratory SOPs, OSHA regulations and cGMP regulations (i.e. Blood borne pathogens and chemical hazards). + Assists Biological Quality Assurance Supervisor in assessing compliance gaps and implementing corrective actions as needed. + Ensures employee training is documented and completed in a timely manner and that appropriate records of training and evaluation are maintained. + Performs laboratory tests in BQA when necessary. + Assists Biological Quality Supervisor in assigning tasks to BQA personnel based on priorities defined by the Production Schedule. + Assists Biological Quality Supervisor in collecting monthly departmental metrics and quarterly metric data for Qualtiy review or management review meetings. + Ensures microbiological testing, investigation and documentation is performed in a timely manner to support investigations. + Performs data entry of test results into database. + Performs and interprets calculations as needed. + Performs all assigned tasks following applicable laboratory SOPs, OSHA regulations and cGMP regulations (i.e. Blood borne pathogens and chemical hazards). + Performs and reports investigations for customer complaints. + Assists with sample collection, testing, data collection and interpretation for validation protocols and study protocols as assigned. + Follows asceptic technique in controlled areas. + Initiates and completes assigned technical projects. + Initiates and completes technical reports. + Performs other duties as assigned by the BQA Supervisor or Director. **Biological Quality Assurance Technical Specialist – QA - Healthcare** **Qualifications** To qualify for the Biological Quality Assurance Technician III, you must experience in a Biological QA laboratory setting. Must be able to visualize bacterial culture media to properly inoculate media for testing and detect color change that may be representative of bacterial growth. Top candidates must be able to distinguish and count small bacterial colonies on agar plates. **Additional requirements of the Biological Quality Assurance Technical Specialist include** : + Bachelor’s degree/Science (BS/BA) from four-year college or university; or equivalent combination of education and experience. + 1+ years’ experience in a highly Regulated/GMP environment + 3-4 years of experience in Environmental Microbiological laboratory setting including experience in laboratory techniques + Interacts with other departments in a professional and productive manner. + Maintains inventory of laboratory supplies. + Maintains a clean and organized working environment **Biological Quality Assurance Technical Specialist – QA - Healthcare** **IMMUCOR, INC IS AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER; MINORITIES/FEMALES/DISABLED/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. **Job Locations** _US-GA-Norcross_ **Job ID** _2022-2906_ **Category** _Quality_
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