QA/QC Specialist - IGM Clinical Admin

Nationwide Children's Hospital•Columbus, OH

About The Position

The QA/QC Specialist coordinates quality control, operational improvement, regulatory compliance, inspection readiness, and education within the Institute for Genomic Medicine. The role assists with troubleshooting and provides technical guidance. It promotes awareness of applicable CAP/CLIA, Joint Commission, and New York State testing requirements and serves as a General Supervisor under CAP/CLIA guidelines and as a Lab Supervisor under New York State testing guidelines, as applicable. The specialist coordinates quality monitoring, investigates incidents and deficiencies, tracks laboratory documentation, supports standard operating procedures, and collaborates on process improvements and new workflows. The role also provides staff education, leads workgroups and projects, troubleshoots technical and customer service problems, and performs secondary technical review and verification of cases before sign-out to support accurate and timely billing and reporting.

Requirements

Bachelor’s degree in chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution, or equivalent education as defined in 42 CFR 493.1405(b)(5)(i)(B).
Two years of laboratory experience.
Organizational skills, attention to detail, and computer experience.
Excellent oral and written communication skills, including the ability to interpret and present information effectively.
Ability to foster interpersonal relationships with internal and external customers.
Flexibility in responding to interruptions and changing circumstances.

Nice To Haves

ASCP certification as an MT(ASCP), MB(ASCP), or CG(ASCP) is preferred.
Experience in cytogenetics, molecular genetics, or molecular biology is preferred.

Responsibilities

Promote compliance with laboratory regulatory requirements and raise awareness of CAP/CLIA, Joint Commission, and New York State testing requirements.
Serve as General Supervisor under CAP/CLIA guidelines and as Lab Supervisor under New York State testing guidelines, as applicable.
Assist with inspections and maintain inspection readiness throughout the year.
Lead group training to educate laboratory staff on quality control and quality assurance responsibilities.
Coordinate the IGM Quality Monitoring program.
Prepare reports, investigate incidents and deficiency reports, and resolve problems related to deviations from established procedures and processes.
Track and review laboratory documentation concerning training and competency, education, and equipment use and maintenance.
Facilitate the creation, updating, activation, and distribution of Standard Operating Procedures.
Collaborate with the supervisor and manager to coordinate process improvements and implement new workflows.
Facilitate and lead workgroups and projects.
Perform in-depth troubleshooting and problem-solving; use quality control information to anticipate and prevent problems and recommend improvements.
Resolve technical, computer, and customer service problems.
Perform secondary technical review and verification of cases prior to sign-out to ensure accurate and timely billing and reporting.