Immucor Research and Development Jobs

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:

  • Conducts compliance audits of complex documentation and data.

  • Performs batch record review tasks to maintain compliance and product release.

  • Understands, reviews and assess change control, validation and qualification documents.

  • Understands and contributes to CAPA and NCR System, including monitoring time to close and identifying trends.

  • Understands Design Control requirements and supports Research & Development to maintain compliance.

  • Review and assess the appropriateness of document changes in accordance with internal procedures.

  • Serves as Quality Assurance interface to other departments, partners and Regulatory Bodies.

  • Prepares appropriate, agendas and meeting minutes without supervision. Monitors the progress of items on meeting agendas and reports progress, as appropriate.

  • Creates and approves policies and procedures, and provide technical review for validations/verifications.

  • Assists in developing Quality systems & make recommendations to existing Quality systems.

  • Contribute to complex technical troubleshooting activities & in-depth evaluations.

  • Develops, analyze, trends, maintains & reports department metrics.

  • Develops & maintains department training programs.

  • Review quality outputs for compliance to internal and external requirements (21 CFR 820, ISO 13485, ISO 14971, MDSAP etc).

  • Assist and own applicable portions of supplier management system, internal audits and complaint system.

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.

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

Where permitted by applicable law, must be fully vaccinated or have an approved Immucor exemption by January 18, 2022 to be considered for U.S.-based job. If not currently employed by Immucor, Inc. Proof of vaccination status will be required on first day of employment.

Job Locations US-WI-Waukesha

Job ID 2021-2851

Category Quality

DirectEmployers