Regulatory Operations Specialist - Lab Compliance & Audits

Foundation Medicine; Boston (MA); On-site; USD 85,000 - 106,000; Full time

Job summary

Foundation Medicine in Boston, MA is seeking a TheRight to Operate Specialist to support regulatory compliance across CLIA, CAP, MA/NY state requirements and internal policies. You will collaborate cross-functionally to prepare documentation and respond to audits, ensuring timely competency reviews and KPI tracking.

You will maintain staff training files, assist with CAPA and non-conformance processes, and help drive continuous improvement in laboratory operations while occasionally traveling up

Qualifications

• Bachelor’s Degree in Biology, Chemistry, or other Life Science field.
• 4+ years of experience in pharma/biotech/medical devices/diagnostics.
• 3+ years of GMP/GLP/GCP exposure.

Responsibilities

• Maintain lab operation staff training and personnel files.
• Support QA in documentation for external audits.
• Follow company policies and procedures.
• Ensure GCP/CLIA/CAP and state compliance.
• Act as operations liaison to internal customers.
• Assist with CAPA, NCR, and audit responses.

Skills

Excellent communication

Detail-oriented

Under pressure

Cross-functional collaboration

Audit readiness

Education

Bachelor's degree in Biology/Chemistry/Life Science

Job description

Foundation Medicine in Boston, MA is seeking a TheRight to Operate Specialist to support regulatory compliance across CLIA, CAP, MA/NY state requirements and internal policies. You will collaborate cross-functionally to prepare documentation and respond to audits, ensuring timely competency reviews and KPI tracking.

You will maintain staff training files, assist with CAPA and non-conformance processes, and help drive continuous improvement in laboratory operations while occasionally traveling up