Senior QA Lab Operations & Compliance Lead

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

Benefits offered by this job

Discretionary annual bonus

Benefits

Job summary

Foundation Medicine in Morrisville, NC is seeking a Senior Specialist, Quality Assurance Laboratory Operations to uphold CLIA, CAP, and FDA standards while improving quality systems and processes.

You will manage QMS activities, reviews, audits, and regulatory inspections, collaborate with cross-functional teams, and support investigations, deviations, CAPAs, and documentation including SOPs and annual product reviews.

Qualifications

• 0-3 years of prior experience with patient testing laboratory quality.
• Bachelor in Science or an equivalent degree.
• Alternatively, an Associate's degree with 5+ years in a clinical laboratory.

Responsibilities

• Assist in the implementation and maintenance of the QMS to ensure CLIA, CAP, and FDA compliance.
• Review and approve information to FMI standards, including NCRs, deviations, CAPA, QC records, and process improvements.
• Provide guidance on GxP guidelines and regulations across the organization.
• Coordinate audit responses and participate in inspections as needed.
• Create, review, and approve SOPs, Quality Metrics Reports, and Annual Product Reviews.
• Travel domestically up to 5% and support internal/external audits.

Skills

Attention to detail

Strong communication

Cross-functional collaboration

Problem solving

Education

Bachelor of Science

Associate degree in laboratory science with 5+ years experience

ASQ/ASCP/AMT certification (preferred)

Tools

MasterControl

Maximo

LIMS

Smartsheet

Job description

Foundation Medicine in Morrisville, NC is seeking a Senior Specialist, Quality Assurance Laboratory Operations to uphold CLIA, CAP, and FDA standards while improving quality systems and processes.

You will manage QMS activities, reviews, audits, and regulatory inspections, collaborate with cross-functional teams, and support investigations, deviations, CAPAs, and documentation including SOPs and annual product reviews.