Laboratory Quality Assurance Coordinator

The Laboratory Quality Assurance Coordinator is responsible for the operation of the laboratory in accordance with established Standard Operating Procedures (SOPs), applicable sections of the Code of Federal Regulations (CFRs), with emphasis on Good Manufacturing Practices (GMPs), the Clinical Laboratory Improvement Act of 1988 (CLIA), and applicable company policies, procedures and quality initiatives. The Quality Assurance Coordinator performs quality assurance activities of the laboratory by performing the following duties personally or through subordinate supervisors.

*Immediately communicates concerns identified in the testing process to the laboratory Quality Assurance Management to ensure that questionable test results are not released.

*Reviews testing, quality control, and other testing reports for accuracy, completeness and compliance to requirements to ensure that quality assurance standards and regulatory requirements are met.

*Releases batch data to Laboratory Operations Management for release of test results to donor centers.

*Participates in audits of laboratory operations, documents audit findings and reports results to Laboratory Quality Assurance Manager and Director of Laboratory Affairs.

*Assists with hosting/coordinating FDA, OSHA, CLIA, ABRA, and other inspections as necessary.

*Maintains familiarity with laboratory operating and quality assurance/quality control procedures and quality system regulations and standards in order to effectively perform laboratory quality assurance functions.

*Assists with and/or advises on laboratory procedure development and implementation as requested or necessary.

*Reviews, tracks and communicates information regarding process variations and quality control samples as required by laboratory quality assurance procedures.

*Maintains current and accurate records of all relevant communications, audits, corrective action plans, and effectiveness monitoring.

Other duties as assigned.Kelly Services is an Equal Opportunity EmployerContact?Information?:.2204 Lakeshore Drive
Birmingham?AL?35209