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National Genetics Institute (NGI), a wholly owned subsidiary of LabCorp, is seeking a Quality Coordinator to join its team in Los Angeles! NGI provides the global plasma industry with comprehensive donor qualification and source plasma donation screening services including advanced genetic testing and viral marker testing (VMT).
The QA Coordinator is an integral member of the Quality department responsible for the overall support and maintenance of Monogram's controlled documents and the continuous assessment/improvement of related systems and processes to ensure compliance with applicable regulatory requirements.
The schedule for this position will be: Monday -- Friday, 8am-5pm
Maintain necessary documents and materials pertaining to licensing requirements
Coordinate payment requests for licensing fees with the Accounts Payable department
Responsible for the administration of and processing new and revised documents (SOPs, forms, change requests, etc.) per established systems.
Maintain quality records as assigned including organization of electronic and hard copy
Inform QA Manager of any significant issues affecting overall laboratory quality including but not limited to audit findings, validations, corrective and preventative
Assist with internal audits in all laboratory sections against GMP, CLIA, CAP, NYS, and ISO as applicable
Participate in in client audits and regulatory inspections as needed
Support quality activities pertaining to process improvement projects based on event reports, client feedback and quality investigations
Support CAPA commitments (internal and external)
Support the review of quality control programs and may assist in establishing parameters for acceptable levels of test performance
Support validation activities
Train NGI employees in quality subjects as assigned
Participate in review and maintenance of employee training records
Interface with regulatory agencies and support regulatory submissions
Bachelor's degree in Biology, Chemistry, Medical Technology or a related science
Minimum 6 months' relevant experience required
Previous experience in a clinical laboratory is highly preferred
General knowledge of laboratory regulations (CAP/CLIA/ISO) and licensing requirements
Basic understanding of audit related requirements and procedures
Working knowledge of quality assurance best practices and procedures
Excellent analytical, critical thinking and problem solving skills
Strong communication skills; both written and verbal
High level of attention to detail with strong organizational skills
Ability to work independently and within a team environment
Strong computer skills with proficiency with MS Office programs