Laboratory Quality Specialist III

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🔥 29 minutes ago

🐎 Kentucky – Remote

🐎 Kentucky – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Lead complex quality investigations to determine true root cause of laboratory quality events, deviations, documentation issues, and assay-related concerns. • Collaborate with laboratory operations, quality teams, and cross-functional stakeholders to develop, implement, and monitor the effectiveness of Corrective and Preventive Actions (CAPAs). • Provide technical guidance and mentoring to junior investigators and quality personnel on investigation methodologies, root cause analysis, and quality documentation. • Deliver training to quality record authors and approvers to promote consistent application of Standard Operating Procedures (SOPs) and investigation best practices. • Support internal audits, client audits, regulatory inspections, and sponsor inquiries as needed. • Perform complex database and quality review of laboratory data, MTM content, source documentation, validation documents, SOPs, and supporting records. • Support change control review and impact assessment, including evaluation of downstream impacts to reporting, study setup, MTMs, DSR-related content, calculations, Tox Grades, LOINC, UOM, custom reference ranges, and custom alerts. • Review laboratory quality records, investigation reports, analytical and bioanalytical reports, and supporting documentation for technical accuracy, completeness, and compliance with internal procedures and regulatory expectations. • Participate in investigation and resolution of quality events, escalations, documentation gaps, and database content questions. • Draft and review internal and external communications related to change controls, custom reports, UOM requests, LOINC, pediatric or custom reference ranges, custom alerts, and other business needs. • Evaluate laboratory trends, quality metrics, and recurring issues to identify opportunities for continuous improvement. • Enter, maintain, and reconcile data in laboratory databases, tracking tools, metrics repositories, and related business applications. • Partner with laboratory leadership, assay development, validation, and operational teams to resolve complex quality issues and support process improvements. • Support toxicity grading version updates, master tox table revisions, coding QC, tox grade output verification, and implementation timelines. • Serve as a quality representative on cross-functional projects involving laboratory quality systems, assay implementation, and operational improvements. • Train or support onboarding of Business Transformation, QIS, MTM, or other global staff on relevant database and quality processes.

🎯 Requirements

• Advanced degree plus 3 years of experience, or Bachelor's degree plus 5 years of experience in quality assurance, quality control, laboratory operations, clinical research, regulated data review, or a related technical field. • Preferred fields of study: Life Sciences, Chemistry, Biology, Medical Laboratory Science, Engineering, Regulatory Science, or related technical field. • Experience conducting complex quality investigations and performing root cause analysis. • Experience developing and implementing CAPAs. • Experience with change control, quality investigations, technical documentation review, analytical data/report review, laboratory database review, or related quality processes. • Experience working in regulated laboratory environments supporting CAP, CLIA, GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), or other GxP quality systems preferred. • Experience supporting laboratory accreditation, regulatory inspections, or client audits preferred. • Experience with laboratory databases, quality systems, document control systems, TrackWise, Preclarus, or similar business applications preferred. • Strong understanding of laboratory operations, quality systems, and regulated documentation practices. • Strong written and verbal communication skills.

🏖️ Benefits

• Must be legally authorized to work in the United States without sponsorship • Must be able to pass a comprehensive background check, which includes a drug screening