Senior QA Lead, Laboratory Operations & Compliance

Foundation Medicine, Inc.; Morrisville (NC); On-site; USD 103,000 - 120,000; Full time

Benefits offered by this job

Benefits

Job summary

Foundation Medicine, Inc. is seeking a Senior QA Specialist in Laboratory Operations to strengthen the Quality Management System and ensure CLIA, CAP, and FDA alignment.

The role involves reviewing records, leading deviation investigations, CAPA discussions, and maintaining GxP standards across the laboratory operations. The candidate will collaborate with cross-functional teams, support audits, and drive process improvements while ensuring data integrity and regulatory compliance.

Qualifications

• 0-3 years of prior experience with patient testing laboratory quality.
• Bachelor's degree in science required; or an Associate's with 5+ years in clinical lab.
• ASQ/ASCP/AMT certification preferred.

Responsibilities

• Assist in operation and maintenance of the Quality Management System (QMS) to ensure CLIA, CAP, and FDA compliance.
• Review and approve information to FMI standards and procedures, including non-conformance, deviation investigations, CAPA, QC records, and process improvement.
• Provide guidance on GxP quality guidelines and regulations (CLIA, CAP, GCP, 21 CFR Part 11, FDA GMP).
• Coordinate audits and responses; support internal/external audits and inspections.
• Create, review, and approve documents (SOPs, Quality Metrics, ARPs).
• Travel up to 5% domestically.

Skills

Quality Assurance

Regulatory compliance

Documentation

Communication

Education

Bachelor's in Science

Associate's in laboratory science

Tools

MasterControl

Maximo

LIMS

Smartsheet

Job description

Foundation Medicine, Inc. is seeking a Senior QA Specialist in Laboratory Operations to strengthen the Quality Management System and ensure CLIA, CAP, and FDA alignment.

The role involves reviewing records, leading deviation investigations, CAPA discussions, and maintaining GxP standards across the laboratory operations. The candidate will collaborate with cross-functional teams, support audits, and drive process improvements while ensuring data integrity and regulatory compliance.