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Immucor, Inc. Quality Assurance Specialist - Field Quality 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 healthcare organizations in need of innovation and productivity. With the right match, we can transform a life together.

We are seeking a Quality Assurance Specialist - Field Quality, primarily responsible for complaint data entry, investigation, review and follow-up, closure, and trend analysis on complaint data. Responsible to monitor progress of complaints and interact with various departments to resolve issues, complete investigations and close complaints.

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 - Field Quality (Manufacturing - QA)

Responsibilities

  1. Maintain quality system compliance with ISO 13485, QSR & IVDD, including creating new/revising existing quality system documentation.

  2. Process customer complaints, inquiries and feedback following Immucor procedure.

  3. Perform initial assessment for potential MDRs and escalate reportable events to Regulatory Affairs

  4. Maintain GMP compliant return evaluation laboratory including equipment calibration, maintenance, cleaning, and gowning per all applicable procedures.

  5. Performs the evaluation of products returned for the purposes of a complaint investigation; performs necessary ERP transactions

  6. Support internal audits as required

  7. Maintain filing archives for all job-related quality records to ensure controlled access is maintained at all times.

  8. Support with compilation of the Complaint Trends, Quality Metrics Scorecard and prepare metrics for Management Review.

  9. Support CAPAs and track activities to completion as required.

  10. Support tracking Internal and Supplier Audit Schedule and completion as required.

  11. Support with preparation of Field Action documentation as required.

  12. Support as backup for review and approve incoming, in-process and final batch records (DHRs) as required; ensure associated NCMRs are processed per procedural requirements; Perform necessary ERP transactions, as required.

  13. Support as backup for line opening and closing in support of manufacturing operations, as required.

  14. Remain up-to-date with current federal and international regulations and industry trends as related to the above listed duties.

Quality Assurance Specialist - Field Quality (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 in proofreading tasks.An ideal candidate for this role can receive direction well and work independently.

Specific qualifications for this quality assurance role include:

  • Bachelor’s degree in a related field

  • 1+ 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

  • Limited overnight travel may be required - 5%

  • Experience with an eDMS, preferred

Quality Assurance Specialist (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

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. If not currently employed by Immucor, Inc. proof of vaccination status will be required no later than first day of employmen t.

Job Locations US-NJ-Warren

Job ID 2022-2953

Category Quality

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