Quality Assurance Associate

Quality Assurance Associate
Location: Morrisville, NC
Work Schedule: Monday–Friday, 9:00 AM–6:00 PM (100% Onsite)
Pay Rate: $37.00/hour
Benefits: Weekly pay, medical, dental, vision, and disability coverage
 

Job Overview

We are seeking a detail-oriented Quality Assurance Associate to support Quality Assurance (QA) and Document Control activities within a regulated clinical diagnostics environment. This role will help maintain quality systems, ensure accurate documentation, and support compliance with applicable regulatory and quality standards. The ideal candidate has at least one year of relevant experience, hands-on document control experience, and a strong interest in quality assurance, regulatory compliance, and laboratory operations.

Job Responsibilities

• Monitor periodic document review requirements by communicating and following up with document owners to ensure timely completion.
• Maintain the quality document lifecycle, including scanning, filing, storing, and archiving records in accordance with established Quality Management System (QMS) procedures.
• Review quality documents for accuracy, clarity, completeness, and alignment with operational requirements.
• Ensure documentation complies with applicable regulatory standards, including CLIA, CAP, NYS, and California requirements.
• Maintain accurate and traceable records in accordance with documentation principles, ensuring information is attributable, legible, original, contemporaneous, and accurate.
• Collaborate with cross-functional teams to support quality improvement initiatives and resolve documentation-related issues.
• Assist with equipment qualification, testing, calibration, and standardization activities before patient testing.
• Support lot-to-lot validation activities for new reagents.
• Assist with nonconformance investigations, root cause analysis, incoming material reviews, and internal audits as needed.
• Perform additional quality assurance and document control duties as assigned.

Required Qualifications

• Bachelor's degree or equivalent relevant experience in Quality Assurance, Compliance, Document Control, Biotechnology, Clinical Laboratory Science, or a related field.
• At least 1 year of relevant professional experience in a quality-related or regulated environment.
• Experience working in biotechnology, pharmaceutical, clinical diagnostics, or other regulated laboratory environments.
• Experience supporting internal audits, document reviews, equipment calibration, or quality investigations.
• Hands-on document control experience is required.
• Familiarity with CLIA, CAP, NYS regulations, and other applicable quality standards.
• Strong interest in Quality Assurance, regulatory compliance, and quality management systems.
• Excellent attention to detail, organizational skills, and ability to manage multiple priorities.
• Strong written and verbal communication skills.
• Ability to work independently and collaboratively in a fast-paced environment.

At Tailored Management, we help people get jobs and take pride in their work, so we better take pride in ours too. Not every company has the opportunity to meaningfully and directly impact individuals in a way that makes their lives tangibly better. To better support our employees, we offer a wide variety of benefit options to support you. We offer:

• Medical Coverage – HDHP, PPO, and Surest plan options
• Minimum Essential Coverage (MEC)
• Dental Insurance
• Vision Insurance
• Short-Term Disability (STD)
• Long-Term Disability (LTD)
• Life & AD&D Insurance
• Critical Illness Insurance
• Accident Insurance
• Employee Assistance Program (EAP)

#TMCA