Quality Manager for PerkinElmer Genetics

General Summary: PerkinElmer Genetics, a state-of-the-art, high-throughput, newborn screening laboratory providing one of the world's most comprehensive programs for detecting clinically significant inherited disorders. The Quality Assurance Manager performs the quality systems duties for laboratory services in compliance with Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP), state laws and various other domestic and international requirements and standards. This position may require up to 20% travel.
Routine Responsibilities:

• Maintain Laboratory Services Quality Management System to ensure the systems are in alignment with the current requirements and operational processes.
• Oversee and maintain Corrective and Preventive Action (CAPA) Program and ensure all quality events are documented, investigated, assessed for impact, root cause and risk, and all associated actions are completed in a timely manner.
• Oversee and maintain the Vendor Management Program by performing periodic reviews of vendors and reference laboratories as well as critical vendor audits.
• Manage the Audit Program by conducting internal process audits; Hosting inspections and cross-site audits.
• Manage the Customer Complaint Program to ensure consistency of complaint intake, investigations and customer follow-up.
• Manage and maintain the Electronic Document Control (EDC) system and records management.Provide guidance over all document types and formats as well as conduct EDC training and troubleshooting.
• Assist in the development and review of test method validation plans and the quality review of reports to support optimization and new product offerings for biochemistry and molecular genetics testing.
• Conduct periodic compliance training and verify personnel training records are maintained, current and inspection ready.
• Maintain, communicate and compile quality metrics and key quality indicates for quarterly management review meetings.
• Collaborate and facilitate effective communication with Laboratory management.