Thermo Fisher Scientific
Laboratory Quality Specialist III
Remote, Kentucky, USA · Mid
No sponsorship$15k-$20kDetected 1 day ago
GCPControlsClinical TrialsClinical ResearchPharmacy PracticeClinical Laboratory TechniquesGMPResearchLeadershipCommunicationProblem SolvingCritical ThinkingMentoringOrganizational SkillsMicrosoft OfficeFood SafetyGxP
About the role
- At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale.
- DESCRIPTION How you will make an impact: As a Laboratory Quality Specialist III, you will play a critical role in protecting the quality and integrity of laboratory testing performed within our Global Central Laboratory (GCL) operations.
- This position is ideal for a laboratory quality professional who combines strong scientific knowledge with exceptional investigation, analytical thinking, and problem-solving skills.
Responsibilities
- 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).
- 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.
- Support CAP and CLIA accredited laboratory operations by ensuring investigations and documentation meet applicable quality standards.
- 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.
Nice to have
- Experience conducting complex quality investigations and performing root cause analysis.
- 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.
Skills
- Strong understanding of laboratory operations, quality systems, and regulated documentation practices.
- Demonstrated expertise in root cause analysis, investigation techniques, and quality decision-making.
- Experience reviewing laboratory assays, assay validation documentation, analytical data, or laboratory quality records.
- Proficiency with Microsoft Office applications and electronic quality management systems.
- Knowledge, Skills, Abilities:
Compensation
- $15k-$20k
Benefits
- Preferred fields of study: Life Sciences, Chemistry, Biology, Medical Laboratory Science, Engineering, Regulatory Science, or related technical field.
Visa & Work Authorization
- Must be legally authorized to work in the United States without sponsorship.
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This listing is sourced directly from Thermo Fisher Scientific's careers page and normalized into a canonical job model.