The Opportunity
We are an established New York clinical laboratory compliance consulting practice helping physician office labs, FQHCs, clinics, urgent care centers, and specialty laboratories achieve and maintain compliance with New York State CLEP and federal CLIA requirements. Our track record includes multi-site laboratory compliance programs across the NY area.
We are expanding and looking for one or two experienced consultants to work with us on a per-diem, project-by-project basis. This is an ideal arrangement for a semi-retired or independent laboratory quality/compliance professional who wants meaningful, well-compensated work without a full-time commitment.
Scope note: Our client work is limited to moderate-complexity testing environments (including limited service laboratories and physician office labs). No high-complexity experience required.
What You'd Work On
- Document creation and review: ownership of client compliance documentation: SOPs, policies and procedures, QC/temperature/maintenance logs, competency assessment records, validation documents, and QMS documentation. You should be able to both build these from scratch and audit/remediate what a client already has.
- Training delivery: Conduct on-site and remote training for client staff on CLEP/CLIA standards, SOPs, quality management systems, and day-to-day compliance practices
- Quality Assurance Program (QAP) development and annual updates
- CLEP permit applications, modifications, and eCLEP submissions
- Plans of Correction in response to Wadsworth/DOH survey deficiencies
- Proficiency testing failure remediation and documentation
- Personnel qualification assessments under the NYS framework (director, supervisor, testing personnel)
- On-site mock surveys and pre-inspection readiness reviews
- ECLRS and communicable disease/lead reporting compliance
Who We're Looking For
Required:
- Deep, hands-on experience with New York State CLEP , not just federal CLIA. You should be fluent with NY-specific standards.
- 5+ years in clinical laboratory quality, compliance, or management (hospital lab, reference lab, or regulatory agency background all welcome)
- Demonstrated ability to independently create, review, and maintain the full document set a moderate-complexity lab needs, SOPs/QAP's, logs, QMS records, competency files etc.
- Comfortable and effective training others, front-line testing personnel through practice administrators
- Comfort working independently, on-site at client locations in the NYC metro area and remotely
- Strong writing skills, Plans of Correction, SOPs, and QAP documents are core deliverables
- Work with lab director(s) on constantly improving lab performance
Preferred:
- Former NYS DOH/Wadsworth CLEP surveyor or reviewer experience
- ASCP or equivalent certification (MT/MLS, DLM)
- Experience with physician office labs and limited service laboratory (LSL) registration
- Deep physician / CLEP lab management experience
The Arrangement
- 1099 independent contractor
- Per-diem / per-project engagements range from as low a a few hours per month.
- $150–$225/hour depending on experience and engagement type
- No minimum hours; work as much or as little as fits your life
- On-site work primarily in Brooklyn and the NYC metro area; substantial remote/document work available
No formal application needed. If this sounds like you, or close, reach out and we'll schedule a brief call. Happy to talk with anyone with real NY CLEP background, even if you're not sure the arrangement fits. A resume or a few sentences on your CLEP experience (permit modifications you've handled, surveys you've remediated, labs you've directed or managed) is helpful but not required before the call.
Pay: $150.00 - $225.00 per hour
Work Location: Hybrid remote in Brooklyn, NY 11234