Responsible Person

Remote Full-time
About the position

Lighthouse Lab Services is partnering with a growing reference laboratory in Bourbonnais, Illinois to identify a Responsible Person (RP) to support regulatory oversight and laboratory compliance activities. This role is ideal for an experienced laboratory professional who is familiar with regulatory frameworks governing reference laboratories and can provide guidance on compliance, validation, and operational standards. This position is part-time and can be performed remotely , with occasional availability for consultation and documentation review onsite. The Responsible Person will play a key role in ensuring the laboratory maintains compliance with applicable regulatory standards and certification requirements.

Responsibilities
• Regulatory Compliance & Oversight
• Serve as the designated Responsible Person for regulatory and certification purposes
• Provide guidance to ensure compliance with applicable regulatory standards and certification requirements
• Review laboratory policies, procedures, and quality documentation
• Support preparation for inspections, audits, and certification reviews
• Ensure testing processes and documentation meet regulatory and accreditation standards
• Laboratory Operations Support
• Advise laboratory leadership on regulatory requirements for reference laboratory operations
• Review validation plans and quality management documentation
• Provide oversight related to test implementation and laboratory workflow compliance
• Support corrective actions and continuous quality improvement initiatives
• Certification & Documentation
• Assist with documentation required for certification and licensing processes
• Review and sign off on regulatory documentation when appropriate
• Maintain awareness of updates to regulatory standards affecting laboratory operations

Requirements
• Bachelor’s, Master’s, or PhD in Clinical Laboratory Science, Microbiology, Chemistry, or a related field
• Prior experience serving as a Responsible Person, Laboratory Director, or Technical Supervisor in a regulated laboratory environment
• Strong knowledge of regulatory frameworks governing reference laboratories
• Experience supporting laboratory certification or accreditation processes
• Excellent documentation review and regulatory compliance skills
• Ability to work independently and provide remote oversight

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