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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 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
As a Sr. Quality Assurance Specialist you will perform root cause analysis and implement corrective action for quality related concerns. You will also be responsible for continual improvement activities (5S, Kaizen, etc.) as well as leading, managing, and effectively communicating lean principles and tools to promote performance improvement throughout the manufacturing/shop floor.
Additional responsibilities include:
Working with manufacturing operations to solve in-house quality concerns as well as reviewing nonconforming product and recommending disposition
Working with employees to identify and develop continuous improvement strategies that will drive operational excellence and increased capacity and cost reductions
Conducting assessments of manufacturing operations to provide focused quality improvement opportunities
Collecting, sorting and reporting data on operations quality performance metrics as well as providing trend analysis of defects occurring at the shop floor
Devising sampling procedures and designing and developing forms and instructions for recording, evaluating, and reporting data
Developing and implementing a shop floor self-audit program, including sharing of findings and determination of proper corrective and preventive actions
Leading cross-functional teams to implement continuous improvements, 5S, standard work, s value stream mapping exercises, and visual standards
Participating in CAPA Review Board, Change Orders meetings and other critical decision-making meetings as required to define and assess impact at the shop floor
Managing the Suppliers Quality Agreements Program
Working with Research & Development in the verification, validation and transfer of Software/Systems and Assay programs
Assisting Operations with process validation and equipment/facility qualification for implementation into production
Representing the Sr. Quality Director and Operations Managers in a variety of forums
Qualifications
Qualified candidates will have a thorough understanding and extensive exposure to lean principles as well as experience in coaching and training lean principles and continuous process improvement. You will also need strong time management, initiative, multi-tasking and communication skills to be successful in this quality assurance role.
Additional requirements include:
Bachelor’s degree in Life Sciences / Engineering or other science related or technical field, required
7-10 years of current experience in Blood Banking, Medical Device, and/or Pharmaceutical industry
5+ years in QA function with relevant experience executing, developing and/or administrating cGMP quality programs
Knowledge of cGMP
Frequent computer/report work, and administration of quality system programs and resources
Demonstrated problem solving and root cause analysis skills
ASQ Certified Quality Auditor (CQA) / Certified Quality Engineer (CQE), preferred
Experience with Trackwise data management system, preferred
Sr. Quality Assurance Specialist (Quality / Lean Manufacturing)
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. Proof of vaccination status will be required no later than first day of employmen t.
Job Locations US-GA-Norcross
Job ID 2022-3105
Category Quality
Immucor is an Equal Opportunity/Affirmative Action Employer; Minority/Female/Disability/Vet; Drug Free Workplace
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