Medical Laboratory Quality Assurance Coordinator, Part-Time, (On-Site, Edison, NJ)

Overview
Avantic Medical Laboratory is seeking a highly motivated Quality Assurance (QA) Coordinator (Part-Time, on-site).

Quality Assurance Coordinator supports the Laboratory Quality Management System and works directly under the supervision of the Director of Quality and Clinical Operations. The QA Coordinator assists in maintaining compliance with CLIA, CAP, HIPAA, state regulatory requirements, and laboratory quality standards. This position is responsible for quality monitoring activities, regulatory readiness, document control, proficiency testing oversight, quality indicator tracking, and continuous quality improvement initiatives while maintaining the ability to perform bench testing as needed.

Essential Responsibilities:

• Assist in the implementation and maintenance of the laboratory Quality Management System (QMS).
• Support CAP accreditation, CLIA compliance, HIPAA compliance, and applicable state regulatory requirements.
• Review CAP checklists and assist with inspection readiness activities.
• Manage and maintain MediaLab compliance and document control systems.
• Assist with policy and procedure review, revision, and document management.
• Monitor quality indicators and quality improvement initiatives.
• Coordinate proficiency testing activities and follow-up investigations.
• Assist with occurrence management, nonconformances, corrective actions, and CAPA investigations.
• Participate in internal audits and quality assessments.
• Review quality control data and quality trends.
• Assist with reagent lot-to-lot verification, instrument comparability studies, and quality validations.
• Monitor competency assessments and staff training records.
• Support regulatory inspections and accreditation surveys.
• Maintain recall, safety notice, and quality records.
• Generate quality reports, metrics, and dashboards using Microsoft Excel and other software tools.
• Collaborate with laboratory supervisors and technical staff to ensure ongoing compliance.
• Perform bench testing and provide operational laboratory support as needed.

Qualifications:

• Bachelor's degree in Medical Laboratory Science, Clinical Laboratory Science, Biology, Chemistry, or related scientific field (required).
• Minimum two (2) years of clinical laboratory experience (required).
• ASCP certification preferred (MLS, MT, MLT, or equivalent).
• Strong preference for candidates with Chemistry and/or Hematology laboratory experience.
• Previous CAP-accredited laboratory experience strongly preferred.
• Experience reviewing and interpreting CAP checklists required.
• Previous quality assurance, quality management, or regulatory compliance experience preferred.

Knowledge and Skills:

• Working knowledge of CLIA, CAP, HIPAA, and laboratory regulatory requirements.
• Demonstrated experience reviewing CAP checklist requirements and supporting inspection readiness activities.
• Experience using MediaLab for document control, competency assessment, inspections, and compliance management preferred.
• Understanding of quality control principles, quality assurance, and quality management systems.
• Knowledge of Westgard Rules, Levey-Jennings charts, quality indicator monitoring, proficiency testing, and statistical quality control concepts.
• Experience reviewing quality control data, proficiency testing performance, and quality investigations.
• Strong analytical, investigative, and problem-solving skills.
• Excellent organizational and documentation skills.
• Advanced Microsoft Excel skills preferred, including data analysis, trending, and reporting.
• Proficiency with Microsoft Word, Outlook, and electronic document management systems.
• Strong computer and data management skills.
• Ability to work independently and manage multiple priorities.
• Strong written and verbal communication skills.

Additional Requirements:

• Willingness and ability to perform bench testing when operationally required.
• Willingness and ability to travel to laboratory patient service centers, collection sites, and satellite locations to perform quality audits, regulatory compliance reviews, competency assessments, document control activities, and inspection readiness evaluations.
• Valid driver's license and reliable transportation required.
• Ability to participate in quality improvement, process improvement, and regulatory compliance initiatives.
• Commitment to patient safety, quality management, and continuous quality improvement.
• Ability to work collaboratively with laboratory leadership, supervisors, technical staff, and collection site personnel.

Ideal CandidateThe ideal candidate is an experienced Medical Laboratory Scientist with a strong Chemistry and/or Hematology background who has hands-on experience with CAP accreditation standards, MediaLab, quality systems, proficiency testing, quality control review, and regulatory compliance activities, and is interested in advancing into a laboratory quality and compliance leadership role.

Part-Time Monday

Competitive compensation is based on experience

Job Type: Full-time

Pay: From $50,000.00 per year

Benefits:

• 401(k)
• Health insurance
• Paid time off

Application Question(s):

• Do you have a valid NJ Driver's License
• Do you have a reliable transportation

Education:

• Bachelor's (Preferred)

Experience:

• Medical LIS: 3 years (Required)

Language:

• Fluent English (Preferred)
• Any other languages (Preferred)

Location:

• Edison, NJ 08820 (Preferred)

Shift availability:

• Day Shift (Required)

Willingness to travel:

• 75% (Required)

Work Location: In person

Salary : $50,000