Develop, revise, and maintain laboratory documents, including SOPs, policies, procedures, and work instructions for quality & compliance within our Labs eQMS.
Ensure that all documents are current, properly formatted, and in compliance with CLIA and CAP regulations and other applicable standards.
Assist in preparing and maintaining documentation for CLIA inspections, CAP accreditation processes and other regulatory audits.
Track and report on the status of document control activities, including updates and compliance.
Identify opportunities for process improvements in document management and control.
Provide leadership and be a resource to staff regarding CLIA, CAP, and related regulations and best practices, including maintaining knowledge of applicable regulations and providing consultation to staff regarding regulatory compliance.
Qualifications:
Bachelor of Science degree in medical technology, laboratory sciences or scientific disciplines
Minimum 5 years of Quality Assurance experience in a lab setting or related industry required
Knowledge and application of CLIA/CAP required
Preferred Qualifications:
Demonstrated ability to work independently, exercise good judgment, and to work collaboratively in an interdisciplinary team
Excellent problem solving and delegation skills with demonstrated leadership ability
Experience with ENSUR eQMS preferred
Experience using and configuring LIS software and knowledge of LIS documentation requirements
Knowledge of GLP preferred
Medical device and/or invitro diagnostics industry experience is a plus
Certification in document control or quality management (i.e. ISO 9001) is a plus but is not required
Knowledge of GMP/ISO requirements, specifically current ISO 13485 Medical Devices.