Spec, Quality Assurance

Job Title: Quality Assurance Specialist
Jo Location: Clifton, NJ
Job Duration: 6+ Months


Shift: 08:00 AM to 4:30 PM
Pay Range: $31.20 - $ 56.12/hr. on W2.
 
Job Summary:
The Quality Assurance Specialist supports and coordinates initiatives that uphold quality standards throughout all phases of laboratory testing — pre-analytical, analytical, and post-analytical. This role ensures processes align with company values, regulatory requirements, and industry best practices.
 
Education: Bachelor’s degree in chemical, physical, biological, or clinical laboratory science, or medical technology – Required
Certifications: Qualification as a General Laboratory Supervisor as defined by CLIA '88 – Required
Experience: Minimum of 3 years in a laboratory setting – Required
 
Licensing & Accreditation:

• Assist in internal inspections of laboratories and collection sites to ensure compliance with federal, state, and local regulations, CAP accreditation standards, and company protocols.
• Serve as a knowledgeable resource on CLIA '88 regulations and CAP accreditation guidelines.

 
Proficiency Testing:

• Ensure participation in proficiency testing for each laboratory test and coordinate necessary corrective actions.
• Oversee the Validity Check Program and Blind Sample Resubmission Program (as applicable).
• Support method comparisons across instruments, methods, and laboratory sites.

 
Quality Assurance & Quality Improvement

• Assist in monthly Quality Assurance (QA) meetings and support department-specific Quality Improvement (QI) plans.
• Monitor and help maintain quality indicators relevant to QA activities.
• Prepare, distribute, and review the QA Manual.

 
Support key programs such as:

• Corporate Quality Surveillance Program
• Patient Results Distribution Program
• Best Practice Team Initiative
• Database Changes Verification Program

 
Quality Reporting & Compliance

• Promptly report all Reportable Quality Issues according to Standard Operating Procedures (SOP).
• Track and document all revised reports in accordance with SOPs.
• Perform other duties as assigned by the Technical Manager.

 
Demonstrated experience in:

• Quality Assurance (QA)
• Statistical Quality Control (SQC)
• Regulatory/Accreditation Compliance (e.g., CLIA, CAP)

 
Work Environment:

• Biohazard Environment — must follow safety and handling protocols.