If you’re a QA expert when it comes to manufacturing, Immucor has an exciting opportunity for you! We are looking to hire a Sr. Quality Assurance Specialist with a background in blood banking, medical device, and/or the pharmaceutical industry. This critical role is responsible for providing quality oversight at the shop floor level to address immediate quality issues. If you’ve got the necessary skills and experience to excel in this role, we want to hear from you!
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.
Sr. Quality Assurance Specialist (Quality / Lean Manufacturing)
Responsibilities
Key Accountabilities
Working with manufacturing operations to solve in-house quality concerns as well as reviewing nonconforming product and recommending dispositionWorking with employees to identify and develop continuous improvement strategies that will drive operational excellence and increased capacity and cost reductionsConducting assessments of manufacturing operations to provide focused quality improvement opportunitiesCollecting, sorting and reporting data on operations quality performance metrics as well as providing trend analysis of defects occurring at the shop floorDevising sampling procedures and designing and developing forms and instructions for recording, evaluating, and reporting dataDeveloping and implementing a shop floor self-audit program, including sharing of findings and determination of proper corrective and preventive actionsLeading cross-functional teams to implement continuous improvements, 5S, standard work, s value stream mapping exercises, and visual standardsParticipating in CAPA Review Board, Change Orders meetings and other critical decision-making meetings as required to define and assess impact at the shop floorManaging the Suppliers Quality Agreements ProgramWorking with Research & Development in the verification, validation and transfer of Software/Systems and Assay programsAssisting Operations with process validation and equipment/facility qualification for implementation into productionRepresenting the Sr. Quality Director and Operations Managers in a variety of forumsQualifications
Minimum Knowledge & Experience required for the position:
Bachelor’s degree in Life Sciences / Engineering or other science related or technical field, required7-10 years of current experience in Blood Banking, Medical Device, and/or Pharmaceutical industry5+ years in QA function with relevant experience executing, developing and/or administrating cGMP quality programsKnowledge of cGMPFrequent computer/report work, and administration of quality system programs and resourcesDemonstrated problem solving and root cause analysis skillsASQ Certified Quality Auditor (CQA) / Certified Quality Engineer (CQE), preferredExperience with Trackwise data management system, preferredSr. Quality Assurance Specialist (Quality / Lean Manufacturing)
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