Key Responsibilities
- 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.
