Specialist, Right to Operate

Role: Support regulatory compliance and quality assurance for a clinical laboratory within the biopharma/diagnostics sector. Responsibilities: maintain staff training/competency, assist in external/internal audits, ensure adherence to GCP, CLIA, CAP, and state regulations, review quality documentation, manage non-conformance reports, support CAPA programs and proficiency testing, respond to audit findings, and drive continuous process improvement. Requirements: Bachelor's in Biology, Chemistry, or Life Sciences; 4+ years in pharma, biotech, or diagnostics industries; 3+ years working with GMP, GLP, or GCP. Preferred: experience with vendor management, internal/external audits, process validation, and handling compliance with HIPAA. HighValue: laboratory operations, regulatory compliance, GCP/GMP/GLP, audits, quality management, proficiency programs. WorkSetup: primarily onsite in Boston, MA; travel up to 10%; flexible outside regular shifts.