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Immucor, Inc. Supervisor, Biological Quality Assurance 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 primary purpose of this position is to provide supervisory leadership to the BQA staff and perform and analyze microbiological testing and environmental monitoring to confirm the quality of products at Immucor, Inc. Additionally, the supervisory role will assist with special projects and protocols for validation and determination of new and revised test methods.

Supervisor, Biological Quality Assurance

Responsibilities

  1. Ensures microbiological testing, investigation and documentation is performed in a timely manner to support investigations.

  2. Assists with preparation of necessary validation protocols, standard operating procedures (SOPs), deviation reports and corrective action reports as required.

  3. Provides technical support/guidance for all BQA related study and validation protocols.

  4. Leads efforts to evaluate the relevance of new microbial product testing methodologies and associated regulatory requirements/impact and support their implementation, as appropriate.

  5. Collaborates effectively with other departments and provide microbiological support when needed.

  6. Reviews data generated by the BQA Department.

  7. Ensures all department employees follow applicable laboratory SOPs, OSHA regulations and cGMP regulations (i.e. Blood borne pathogens and chemical hazards).

  8. Assists Associate Director, Quality Operations in assessing compliance gaps and implementing corrective actions as needed.

  9. Ensures employee training is documented and completed in a timely manner and that appropriate records of training and evaluation are maintained.

  10. Completes investigations, root cause analyses, and reports for Microbiological out-of-specification results and deviations.

  11. Performs laboratory tests in BQA when necessary.

  12. Assigns tasks to BQA personnel based on priorities defined by the Production Schedule

  13. Assists with special projects and other duties assigned by the Associate Director, Quality Operations in collecting monthly departmental metrics and quarterly metric data for Quality review or management review meetings.

  14. Maintains personnel time sheets.

  15. Performs employee appraisals and competency evaluations.

  16. Assists with special projects and other duties assigned by the Associate Director, Quality Operations.

Additional Responsibilities:

  1. Participate in Internal Audit Program

  2. Perform Change Control Assessments for BQA as required

  3. Participate in CAPA Review Board as Required

Supervisor, Biological Quality Assurance

Qualifications

Minimum of BS/BA degree required (Microbiology preferred or Biology/Medical Laboratory Science).

Minimum of 2-4 years of experience in a Microbiological laboratory setting including experience in laboratory techniques.

Prior supervisory experience desirable.

Must be available to work flexible hours as necessary to support production schedules.

Supervisor, Biological Quality Assurance

IMMUCOR, INC IS AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER; MINORITIES/FEMALES/DISABLED/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-GA-Norcross

Job ID 2021-2534

Category Quality


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