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Transfusion Medicine Compliance Officer - Pathology Admin - F/T - Days

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POST DATE 9/14/2016
END DATE 12/12/2016

University of California- Irvine Orange, CA

Orange, CA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)
Bachelors Degree


Position Summary:

Reporting to the Laboratory Quality & Safety Manager, incumbent serves as a subject matter expert in Transfusion Medicine regulatory affairs and quality assurance, providing consultative services for department leaders. Uses specialized knowledge for reports, external inspections, responding to inspection deficiencies and setting policy for quality assurance and compliance activities. This position performs duties of an information system super user for software and databases associated exclusively with Transfusion Medicine. Responsible for development, maintenance and enforcement of the quality plan.

Salary Range:

Rate Minimum $69,600.00 Maximum $124,600.00

Required Qualifications:

Ability to design, administer and critically evaluate policies, procedures and processes against regulatory requirements

Ability to maintain a work pace appropriate to the workload

Advanced knowledge and experience/expertise in related field

Bachelor s degree or higher in Biology or related field

Current CA CLS license

Excellent written and verbal communication skills in English

Extensive experience with instrument troubleshooting, repair, testing and verification of system integrity.

Familiar with Microsoft Office applications

Six years of experience in Blood Bank or Blood Donor Center

Knowledge of Good Laboratory Practices (FDA, CAP, TJC, AABB, CADPH).

Must demonstrate customer service skills appropriate to the job

Must possess the skill, knowledge and ability essential to the successful performance of assigned duties

At least one year of experience with regulatory compliance

Preferred Qualifications:

Master s degree or certified Quality Manager

Physical, Mental & Environmental Demands:

To comply with the Rehabilitation Act of 1973 the essential physical, mental and environmental requirements for this job are listed below. These are requirements normally expected to perform regular job duties. Incumbent must be able to successfully perform all of the functions of the job with or without reasonable accommodation.