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

Overview

We are seeking a Quality Assurance Specialist III to join our team. This position is responsible for ensuring that the company maintains compliance with applicable external regulations (21 CFR 820, ISO 13485, QSR, and IVDD) and internal quality system requirements. In addition, this position is responsible for creating new/revising existing quality system documentation.

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.

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 III (Manufacturing - QA)

Responsibilities

As a Quality Assurance Specialist, you will review and approve incoming, in-process and final batch records (DHRs) and ensure associated NCMRs are processed per procedural requirements.

Specific duties for this role include, but are not limited to:

  • Maintain Quality quarantine, retain and other QA inventory areas.

  • Perform necessary ERP transactions including but not limited to raw material, intermediation and product release.

  • Perform line opening and closing in support of manufacturing operations.

  • Maintain NCMR (including Material Review Board), Deviation, and Rework systems; open, review and approve such documents as required.

  • Trend quality metrics via scorecard and present data to manager, as applicable.

  • Review and approve (as applicable) facility and equipment validation protocols, executed protocols and reports.

  • Mentor and train staff in quality system procedures and general regulatory compliance requirements.

  • Identify and lead continuous improvement projects with cross-functional projects with cross-functional team members.

  • Develop, implement and maintain quality system processes form a site level perspective.

  • Drive site internal audit program by performing and reviewing audits as assigned.

Quality Assurance Specialist III (Manufacturing - QA)

Qualifications

We are looking for a highly organized and detail-oriented Quality Assurance Specialist that has exceptional organizational skills with a keen eye for detail for proofreading tasks. Someone who can receive direction well and work independently will be a good fit for this role.

Specific qualifications for this quality assurance role include:

  • Bachelor’s degree in a related field

  • 4+ years of relevant medical device, pharmaceutical and/or IVD experience required

  • Working knowledge of 21 CFR 820, ISO 13485, EU IVDD

  • Excellent verbal and written communication skills

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

  • Overnight travel will be required - 10-20%

  • ASQ Certified Quality Engineer and/or Auditor preferred

  • Experience with an eDMS preferred

Quality Assurance Specialist III (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 ID 2018-1807

Category Quality