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Job Information

Immucor, Inc. Quality Specialist II in Waukesha, Wisconsin

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 seeking a Quality Specialist II (Quality Assurance Specialist) to join our team. This position is responsible for quality assurance compliance activities under the direction of the Quality & Regulatory Affairs.If you’ve got the necessary skills and experience to excel in this position, we want to hear from you. Apply today!

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 .

Quality Assurance Specialist II (Manufacturing - QA)

Responsibilities

As a Quality Specialist, you will be part of the team that is responsible for coordinating and executing all activities necessary to maintain compliance with GMP and ISO 13485 and the integrity of the Quality Management System.

Specific duties for this role include:

  • Performing tasks within the Document Control Requirements to maintain compliance

  • Performing tasks within the Label Control Requirements to maintain compliance

  • Reviewing and assessing the appropriateness of document changes in accordance with Change Control requirements of a difficult and complex nature

  • Leading internal audits

  • Serving as QA interface to other departments, partners and regulatory bodies

  • Preparing appropriate, agendas and meeting minutes without supervision

  • Monitoring the progress of items on meeting agendas and reporting progress, as appropriate

  • Creating and approving policies, procedures, and regulatory protocols and providing technical review for validations

  • Assisting in developing quality systems and making recommendations to existing quality systems

  • Conducting complex technical troubleshooting activities and in-depth evaluations

  • Developing, analyzing, maintaining & reporting department metrics

  • Developing and maintaining department training programs

  • Reviewing and assessing the appropriateness of document changes in accordance with internal procedures of a difficult and complex nature

  • Responsibility for Batch Record compliance and product release

Quality Assurance Specialist II (Manufacturing - QA)

Qualifications

We are looking for a highly organized and detail-oriented Quality Specialist that has exceptional organizational skills with a keen eye for detail in proofreading tasks. Ideal candidates can receive direction well and work independently.

Specific qualifications for this quality assurance role include:

  • Bachelor’s degree in a related field

  • Working knowledge of QC, manufacturing and inventory processes

  • Working knowledge of Microsoft Word, Excel and related functions including formulation of graphs

  • Exceptional organizational skills

  • Ability to proofread controlled documents with a keen eye for detail

  • Ability to follow instructions and work independently

  • Excellent verbal and written communication skills

  • Proficient with Microsoft Excel, Word, Access, and Outlook

Quality Assurance Specialist II (Manufacturing - QA)

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-WI-Waukesha

Job ID 2020-2463

Category Quality


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