Quality Specialist - Lab Operations Oversight

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day as we enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve their career goals while helping to take science a step beyond by developing solutions to some of the world’s toughest challenges, including protecting the environment, ensuring food safety and supporting the development of life-changing therapies.

Summary As the Quality Specialist – Lab Operations Oversight, you will provide Quality oversight and leadership for GMP laboratory activities, ensuring that laboratory operations, documentation, testing practices, and associated Quality records comply with applicable regulatory requirements, company procedures, and data-integrity principles. The primary focus of this role is to provide effective, independent Quality oversight of laboratory operations, identify and communicate compliance risk, support timely resolution of laboratory Quality issues, and promote a state of inspection readiness and sustained Quality performance. Essential Functions Provide Quality review and approval of laboratory documentation, protocols, reports, investigations, deviations, and other GMP records to ensure completeness, accuracy, compliance, and adherence to approved procedures and data-integrity expectations. Review and approve out-of-specification (OOS) and out-of-trend (OOT) investigations, laboratory deviations, corrective and preventive actions (CAPAs), and risk assessments, applying sound Quality and technical judgment to ensure appropriate investigation, root-cause evaluation, impact assessment, and corrective action. Serve as the primary Quality liaison for laboratory and cross-functional teams, providing Quality guidance, interpreting applicable requirements, and supporting timely resolution and escalation of laboratory-related Quality and compliance issues. Partner with Quality Project Leads and participate in client meetings, serving as a Quality subject matter expert for laboratory investigations and associated Quality-system activities. Support Client Business Review meetings by presenting and discussing laboratory investigation trends, Quality metrics, and Key Performance Indicators, as appropriate. Support the generation, review, and assessment of quarterly and annual laboratory trend reports and other Quality metrics to identify recurring issues, emerging risks, and opportunities for improvement. Perform GEMBAs and other Quality oversight activities within laboratory areas to assess adherence to procedures, GMP requirements, documentation practices, data-integrity expectations, and established Quality standards. Conduct in a manner that promotes compliance, open communication, proactive risk identification, and a strong culture of Quality. Partner with laboratory leadership and key stakeholders to proactively identify compliance risks, evaluate Quality-system performance, and support appropriate actions to maintain a compliant state. Promote laboratory inspection readiness through routine Quality oversight, identification and escalation of compliance gaps, and support for sustainable remediation and continuous improvement. Monitor laboratory Quality performance, evaluate trends and recurring issues, and support the development and implementation of sustainable improvements that strengthen compliance, operational effectiveness, and the laboratory Quality system. Build effective working relationships across Quality, laboratory, Operations, project teams, and