Associate Director of Integration and Project Management
Job in
Hamilton Township, Mercer County, New Jersey, USA
Listed on 2026-09-12
Listing for:
MDL Career Site
Full Time
position Listed on 2026-09-12
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Regulatory Compliance Specialist
Job Description & How to Apply Below
Job Summary
The Endocrinology & Chemistry Supervisor is responsible for the technical, operational, and administrative oversight of the Endocrinology and Chemistry testing sections. This role ensures accurate, timely, and compliant testing while supervising laboratory personnel, maintaining quality management systems, and ensuring strict adherence to CLIA, CAP, NYSDOH, and state regulatory requirements. The Supervisor performs high-complexity testing within their scope, manages assay validations, serves as a subject matter expert for staff, and drives continuous quality improvement across the department.
Essential Functions:Technical & Clinical Operations
- Perform, verify, and release high-complexity patient testing in Endocrinology and Chemistry in strict accordance with established Standard Operating Procedures (SOPs).
- Oversee the daily routine, preventive maintenance, calibration, and troubleshooting of automated and semi-automated chemistry analyzers, immunoassay platforms, and related instrumentation.
- Monitor and evaluate quality control (QC) data, Levey-Jennings charts, and multi-rule (Westgard) evaluations; implement and document corrective actions for out-of-control events.
- Lead assay validations, method comparisons, lot-to-lot parallel testing, reference range studies, and carryover studies prior to clinical implementation.
- Investigate, document, and resolve analytical failures, reagent/specimen integrity issues, instrument downtime and non-conformances.
- Oversee proficiency testing (PT) programs, reviewing PT evaluation reports, and executing root-cause analyses/corrective actions for unacceptable results.
- Provide direct daily supervision to bench technicians, ensuring optimal workflow execution, equitable task distribution, and bench coverage.
- Train, mentor, and onboard technical personnel; design training modules and ensure required initial and annual competency assessments are completed and documented on schedule.
- Manage staff scheduling and bench assignments to maintain optimal turnaround times (TAT) and operational efficiency.
- Serve as the primary technical resource and escalation contact for complex troubleshooting, analytical discrepancies, and bench questions.
- Maintain full operational readiness for CLIA, CAP, NYSDOH, and state regulatory inspections.
- Audit laboratory logs, patient records, quality metrics, and maintenance files regularly to ensure complete and audit-ready documentation.
- Assist with internal quality audits and Root Cause Analysis initiatives.
- Author, review, and update department SOPs in compliance with CLIA/CAP standards and manufacturer guidelines.
- Monitor reagent and consumable inventory.
- Proactively identify and resolve operational bottlenecks to support continuous process improvement.
- Enforce chemical, biological and workplace safety guideline, ensuring proper use of personal protective equipment (PPE) and compliance with OSHA standards.
- Maintain strict patient confidentiality (HIPAA) and adhere to corporate compliance guidelines.
- Perform other related duties as assigned or required by laboratory leadership.
- Performs other similar or related duties as required or assigned.
- Assures activities are conducted in a safe manner and materials are handled according to safety guidelines.
- Participates as a team member and is accountable for own work responsibilities.
- Assures information is delivered in a manner that is supportive, timely and understandable.
- Initiative is demonstrated to proactively diagnose and resolve problems.
- Productive work habits are consistently displayed.
- Accuracy and quality are maintained for all activities.
- In-depth expertise in clinical chemistry, automated immunoassay systems, and endocrinology methodologies.
- Strong working knowledge of CLIA, CAP, and NYSDOH regulatory standards.
- Proficiency with Laboratory Information Systems and automated middleware systems.
- Excellent problem-solving, critical-thinking, analytical troubleshooting, and communication skills.
- Demonstrated leadership capability with a focus on team engagement, accountability, and quality work habits.
- Ability to sit, stand, and walk for extended periods during bench operation and administrative tasks.
- Fine motor skills and manual dexterity required for standard laboratory operations (e.g., pipetting, instrument maintenance, specimen handling).
- Proficient visual…
Position Requirements
10+ Years
work experience
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