Laboratory Quality Assurance Coordinator - 3rd Shift - 11pm-7:30am

SUMMARY:

This position is responsible for performing quality assurance functions in the laboratory, including the review of test records, reviewing records, monitoring employee practices, assessing activities for compliance to procedures, and keeping management informed of any quality concerns related to the laboratory operation.

 

RESPONSIBILITIES:

1. Reviews all laboratory product test records, and other records as required by procedures, for completeness, correctness, and compliance to product test specifications.

2. Assists with the preparation of and/or reviews equipment and/or software validation protocols, as requested.

3. May perform the calibration needed in the laboratory.

4. Assists laboratory management in the planning, implementation and follow-up of corrective action.

5. Monitors the preventive maintenance program of laboratory instruments and equipment for the timeliness of performance and reviews the results.

6. Reviews the proficiency tests of laboratory personnel.

7. Monitors for timely resolution of any error and/or accident reporting initiated in the laboratory.

8. Reviews and assesses laboratory activities; reports any procedural or practice non-compliances to the laboratory supervision, Laboratory/Processing Center Quality Assurance Supervisor, or Laboratory Director.

9. Keeps Corporate Quality Assurance informed of quality concerns; serves as liaison between the laboratory and Corporate Quality Assurance and Regulatory Affairs.

10. Performs other duties as may be required/assigned.

 

QUALIFICATIONS:

•High School Diploma or equivalent required.

•A bachelor’s degree in a chemical, physical, biological, or clinical laboratory science or in medical technology; or experience in a clinical laboratory; or training in viral marker test procedures.

•A degree in Medical Technology, certified under an approved agency, and a state supervisor’s license, or be eligible for, if required by the state in which employed, are desired. •

Previous Quality Assurance experience desired.

•Must have good interpersonal, communication, and organizational skills.

 

EEO Minorities/Females/Disability/Veterans

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