Quality Assurance Specialist

Overview Job Title: Laboratory Quality Assurance Specialist Mode of working: Full-time onsite About the Company: Amoy Diagnostics (AmoyDx) is an R&D based diagnostic company, focusing on molecular diagnostics for oncology precision medicine. With completely independent intellectual property rights of ADx-ARMS®, Super-ARMS®, ddCapture® and ADx-HANDLE® technologies, AmoyDx has a market-leading portfolio of molecular diagnostic assays. At AmoyDx, our mission is to improve healthcare and patients' lives with superior & innovative products and services. Our vision is to be one of the global leading and most reliable suppliers of quality diagnostic products and services for personalized healthcare. Job Summary: The Quality Specialist plays a critical role in supporting the Quality Management System (QMS) for AmoyDx US Laboratory, a CLIA-certified and CAP-accredited facility with NYSDOH permit requirements. This junior-level role is ideal for candidates with 2+ years of clinical laboratory quality or regulatory experience, preferably within a New York State–licensed clinical laboratory. The Quality Specialist will assist in implementing, maintaining, and improving quality processes to ensure full compliance with CLIA, CAP, and NYSDOH regulations. This includes document control, quality records management, audit readiness, equipment qualification support, training records, proficiency testing coordination, and nonconformance/CAPA tracking. Responsibilities Quality Management System (QMS) Support Maintain controlled documents (SOPs, forms, logs, templates) in accordance with internal QSPs and regulatory standards. Manage document lifecycle: creation, revision control, approval workflows, issuance, archival. Ensure compliance with Good Documentation Practices (GDP) and internal QA policies. Regulatory Compliance (CLIA, CAP, NYSDOH) Support routine monitoring of compliance with CLIA, CAP checklists, and NYSDOH requirements. Assist with preparation of CAP inspections, NYSDOH and external audits. Track regulatory updates and help communicate relevant changes to laboratory teams. Quality Records & Data Integrity Deviations / non-conformances CAPA actions Complaints and client feedback Temperature logs, maintenance logs, quality indicators Ensure all quality records are complete, accurate, and audit-ready. Training & Competency Management Support onboarding documentation, training records, and competency assessments. Ensure annual competencies, 6-month reviews (as applicable), and initial training are properly documented. Equipment & Facility Compliance Assist with equipment IQ/OQ/PQ file management. Maintain calibration and preventive maintenance schedules, ensuring timely execution and documentation. Verify vendor service reports, certificates, and traceability records. Audit Support & Continuous Improvement Prepare audit materials and ensure all documents are current. Support root-cause analysis (5-Whys, Fishbone, RPN scoring) for NC/CAPA. Monitor quality metrics and generate monthly QA summaries. Supplier approvals and maintenance Receiving, part # creations and maintaining log/tracker SDS Maintenance Additional QA/Operational Support Support validation and verification documentation assembly for IHC, PCR, NGS, and other assays. Assist with reagent lot release documentation and change control forms. Perform additional duties as required to support laboratory operations and quality activities. Qualifications Education & Experience: Bachelor’s degree in biology, medical laboratory science, biotechnology, or related field preferred. Minimum 2 years of experience in a clinical laboratory quality or regulatory role. Experience in a NYSDOH-licensed laboratory strongly preferred. Familiarity with CLIA, CAP accreditation, and NYS Clinical Laboratory Evaluation Program (CLEP) requirements. Skills Clear understanding of laboratory QMS principles and GDP. Experience with document control. Excellent communication, organization, and record-keeping skills. Detail-oriented, able to work independently, and proactive in identifying quality gaps. Physical Requirements: Ability to sit, stand, and perform repetitive tasks for extended periods (approximately 50% each). Ability to lift up to 25 pounds as needed. Other requirements: Must be legally authorized to work in the United States without employer sponsorship. Notes This job description is intended to provide a general overview of the role and does not represent an exhaustive list of all duties, responsibilities, and qualifications required. Employees may be assigned additional tasks as necessary to meet business and regulatory needs. Equal Employment Opportunity & Pay Transparency Equal Employment Opportunity Statement We are an Equal Opportunity Employer and are committed to fostering a diverse and inclusive workplace. Employment decisions are made without regard to race, color, religion, creed, sex, sexual orientation, gender identity or expression, age, national origin, disability, genetic information, marital status, veteran status, or any other characteristic protected under applicable federal, state, or local law. Pay Transparency Statement In compliance with New York State law, we are providing the anticipated compensation range for this position. The pay range for this role is $30.00 – $35.00 per hour , depending on the candidate’s qualifications, skills, experience, and work location. #J-18808-Ljbffr