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Immucor, Inc. Sr. Quality Assurance Specialist in Warren, New Jersey

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 health-care 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 in our Warren, NJ office! 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 as well as 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.

Job Locations US-NJ-Warren

Job ID 2019-2063

Category Quality


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