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Immucor, Inc. Quality Assurance Specialist in Norcross, Georgia

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.

The Quality Assurance Specialist assists in the development and preparation of reports and presentations. Assists with training and cross training of other staff on the Quality Operations procedures. Reviews and approves documentation including but not limited to OOSs, deviations, root cause investigations, CAPAs, protocols, reports, procedures, change orders, post market surveillance sub-reports, etc. This is a Hybrid role- 3 days in office, 2 days remote.

If you self-sufficient and love to learn, this might be the best position for you, don't wait, 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/Quality Operations

Responsibilities

The Quality Assurance (QA) Specialist assists the Quality Operations Management in the maintenance, archiving and retrieval of documentation and data as they pertain to Quality Assurance subsystems deliverables including but not limited to: Quality Review Board (QRB), Management Review Board (MRB) and Change Control Review Board, etc.

  • Serves as subject matter expert (SME) for quality systems processes (i.e., deviation mananagement, corrective and preventive actions (CAPA), trending, change control etc.

  • Conducts audit readiness assessments (IVDR,IVDD, MDSAP, ISO13485), evaluate results and present findings to management and cross-functional teams.

  • Performs root cause analysis and implements CAPAs for quality related concerns.

  • Supports the internal audit program. Able to become an internal auditor.

  • Participates in the development and maintenance of change control workspaces, for proofing, filing, copying, scanning, archiving and retrieval of relevant documentation. Responsible for processing change control requests in a timely manner.

  • Creates and distributes weekly change control update notifications and schedules appropriate individuals as needed to attend weekly change control meetings.

  • Creates and maintains change control tracking system. Prepares change controls metrics.

  • Gathers quality systems process data linked to QRB/MRB,CRB from responsible departments. Organizes and maintains quality systems process data to ensure quick identification and easy retrieval during internal or external audits.

  • Participate in CAPA Review Board, Change Control meetings and other critical decision-making meetings as required to define and assess impact.

  • Represent the Quality Management Team in a variety of forums as deemed necessary.

Quality Assurance Specialist/Quality Operations

Qualifications

Requirements for the Quality Assurance Specialist include:

  • Bachelor's degree (BA/BS) from a four-year college or university; or equivalent combination of education and experience.

  • Bachelor in a life science, preferred

  • Quality certification, such as CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor), a plus

  • Itermediate or advanced Excel and Powerpoint, preferred

Additional requirements:

  • Sound judgment and decision making skills

  • Strong time management, multi-tasking and all round communication skills

  • A self-manager who is productive, takes initiative and seeks opportunities for improvement

  • Proven track record of demonstrated problem solving and root cause analysis skills

  • Effective presentation/communication skills, project/resource management skills

  • Ability to work independently and in a team environment

  • Ability to manage frequent computer/report work, and administration of quality system programs and resources.

Quality Assurance Specialist/Quality Operations

IMMUCOR, INC IS AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER; MINOTIRY/FEMALE/DISABILITY/VET; *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. If not currently employed by Immucor, Inc. proof of vaccination status will be required no later than first day of employment.

Job Locations US-GA-Norcross

Job ID 2022-3045

Category Quality

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