Lab Regulatory & Quality Compliance Specialist

Foundation Medicine, Inc.; Morrisville (NC); On-site; USD 64,000 - 106,000; Full time

Job summary

Foundation Medicine, Inc. in Boston, MA is seeking a Right to Operate Specialist to support the Clinical Laboratory in complying with state, local and federal regulations and internal policies.

This role collaborates cross-functionally to support client requests and audit responses. Responsibilities include maintaining staff training records, supporting QA during external audits and CAPA, reviewing competency forms and ensuring adherence to CLIA, CAP, MA, and NY state regulations, with travel up

Qualifications

• Bachelors Degree in Biology, Chemistry, or life science field.
• 4+ years of experience in pharmaceutical/biotech/diagnostic industries.
• 3+ years of GMP/GLP/GCP experience.

Responsibilities

• Maintain lab operation staff training/personnel files.
• Support QA in documentation and external audit requests.
• Follow company policies and applicable procedures.
• Adhere to CLIA, CAP, MA, NY state regulations.
• Act as a laboratory operations liaison to internal customers.
• Review competency assessment forms and KPI metrics.

Skills

HIPAA knowledge

Audit experience

Attention to detail

Communication skills

Education

Bachelor's Degree in Biology, Chemistry, or other Life Science field

Job description

Foundation Medicine, Inc. in Boston, MA is seeking a Right to Operate Specialist to support the Clinical Laboratory in complying with state, local and federal regulations and internal policies.

This role collaborates cross-functionally to support client requests and audit responses. Responsibilities include maintaining staff training records, supporting QA during external audits and CAPA, reviewing competency forms and ensuring adherence to CLIA, CAP, MA, and NY state regulations, with travel up