Are you motivated to participate in a dynamic, multi-tasking environment? Do you want to join a company that invests in its employees? Are you seeking a position where you can use your skills while continuing to be challenged and learn? Then we encourage you to dive deeper into this opportunity.
NeoGenomics is looking for a temporary, remote, Quality Audit Specialist who wants to continue to learn in order to allow our company to grow.
Now that you know what we're looking for in talent, let us tell you why you'd want to work at NeoGenomics:
As an employer, we promise to provide you with a purpose driven mission in which you have the opportunity to save lives by improving patient care through the exceptional work you perform. Together, we will become the world's leading cancer reference laboratory.
Position Summary:
As a Quality Audit Specialist, you will maintain the effectiveness of both the external and internal audit program. This position collaborates with the organization to maintain a constant state of regulatory compliance and ensuring customer satisfaction by providing outstanding quality services.
Core Responsibilities:
- Support NeoGenomics Pharma Services onsite external audits, regulatory audits and NeoGenomics internal audits to assure timely scheduling and execution of the audit schedule
- Manage the inspection backroom during regulatory inspections to facilitate the timely delivery of requested documents and support readiness activities for external client audits.
- Support inspection readiness audits prior to external client audits to ensure compliance. Includes inspection readiness and audit participation for selected areas as applicable. Works with functional team leaders for audit readiness.
- Conducts assigned internal audits as per defined schedule, documents audit findings, reports to Management and coordinates follow-up activities as required.
- Conduct mock interviews for subject matter experts (SMEs) during inspection preparation
- Support Clinical Trials/Pharma by supporting and performing QA audits including oversight of specific projects, IT/assay validations, vendor qualification and monitoring as assigned; includes conducting tracer audits.
- Ensure that quality initiatives, measures and corrective action plans are communicated and implemented.
Experience, Education and Qualifications:
- Bachelor of Science in healthcare related field required
- At least 1 year of experience in laboratory regulations, Quality Assurance (QA) or healthcare industry related field. Proficient with MS Office programs
- Knowledgeable of federal and state laws and regulations concerning clinical laboratory testing procedures and results. (CAP/CLIA, NY State, ISO 15189/13485, FDA 21CFR820)
- Knowledge of regulations and standards affecting medical diagnostics.
- Ability to work under deadline pressure and extra hours if needed on assignments.
- Proficient with MS Office programs
- Detail-oriented, proven problem solver and analytical thinker with exceptional organization skills. Knowledge and exposure to Lean Six Sigma tools preferred.
