Quality Assurance Specialist
Listed on 2026-01-05
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Quality Assurance - QA/QC
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Healthcare
Data Scientist, Medical Science
Job Title:
Laboratory Quality Assurance Specialist
Mode of working:
Full-time onsite
Amoy Diagnostics (Amoy Dx) 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®, dd Capture® and ADx-HANDLE® technologies, Amoy Dx has a market-leading portfolio of molecular diagnostic assays.
At Amoy Dx, 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 Amoy Dx 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.
Duties and 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.
- 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.
- 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.
- Support onboarding documentation, training records, and competency assessments.
- Ensure annual competencies, 6-month reviews (as applicable), and initial training are properly documented.
- 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.
- 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
- 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.
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.
- 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.
- Ability to sit, stand, and perform repetitive tasks for extended periods (approximately 50%…
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