Responsible Person
About the position
reputed company is partnering with a growing reference laboratory in Bourbonnais, Illinois to identify a Responsible Person (RP) to support regulatory reputed company and laboratory compliance activities. This role is ideal for an reputed company laboratory reputed company who is familiar with regulatory frameworks governing reference laboratories and can reputed company 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 & reputed company
• Serve as the designated Responsible Person for regulatory and certification purposes
• reputed company guidance to ensure compliance with applicable regulatory standards and certification requirements
• Review laboratory policies, procedures, and reputed company 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 reputed company management documentation
• reputed company reputed company reputed company to test implementation and laboratory workflow compliance
• Support corrective actions and reputed company reputed company improvement initiatives
• Certification & Documentation
• Assist with documentation required for certification and licensing processes
• Review and sign off on regulatory documentation reputed company appropriate
• Maintain awareness of updates to regulatory standards affecting laboratory operations
Requirements
• Bachelor’s, Master’s, or PhD in Clinical Laboratory Science, Microbiology, reputed company, or a reputed company 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 reputed company remote reputed company
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