Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
Position Summary
The Operations, Investigations & Procurement Analyst supports the reliable and compliant execution of Clinical Trial Division operations. The position focuses primarily on quality investigations, root cause analysis, CAPA and change control management, and procurement activities supporting operational supply needs. It also provides coverage for warehouse processes, with close attention to safety, product integrity, inventory accuracy, and applicable GxP requirements.
The role works cross-functionally with Operations, Quality Assurance, Finance, internal stakeholders, and external suppliers to resolve issues, maintain continuity of supply, improve processes, and support a culture of Integrity, Intensity, Innovation, and Involvement.
Key Responsibilities
Investigations and Quality Systems
- Lead and document deviation and discrepancy investigations, including timely record initiation, evidence gathering, root cause analysis, impact assessment, and clear, technically sound conclusions.
- Manage investigations, CAPA, change control, data integrity, and audit-related actions in TrackWise or other applicable quality systems, including follow-up to closure within established timelines.
- Define, coordinate, and monitor corrective and preventive actions; verify that actions are completed and assess their effectiveness in collaboration with Quality Assurance and process owners.
- Support rapid investigations and escalation of operational events, ensuring appropriate containment, communication, documentation, and follow-up.
- Analyze recurring issues, quality metrics, overdue records, and operational trends to identify risks and recommend sustainable improvements.
- Support internal and external audits by preparing records, coordinating responses, and tracking assigned actions to closure.
- Contribute to continued process verification and maintain focus on agreed operational and quality KPIs.
Procurement and Supplier Coordination
- Coordinate procurement activities for operational supplies, materials, and services, ensuring requests are complete, appropriately approved, and aligned with business needs.
- Obtain and compare supplier quotations; assess price, availability, lead time, service, and other relevant factors to support purchasing decisions.
- Support supplier negotiations and communicate requirements and expectations, within assigned authority and applicable procurement procedures.
- Track purchase orders, deliveries, backorders, and supplier commitments; proactively communicate risks that may affect operational continuity.
- Maintain accurate purchasing records and supporting documentation, including quotations, approvals, supplier communications, and order status.
- Collaborate with Finance, Procurement, Operations, and other stakeholders to resolve invoice, delivery, quality, and service issues.
- Escalate supplier performance or supply risks and support supplier reviews or improvement actions as required.
Warehouse and Operational Coverage
- Provide operational coverage for receiving, storage, picking, packing, shipping, and inventory activities as needed.
- Follow applicable SOPs and safety requirements when handling materials, including sensitive, hazardous, and temperature-controlled products.
- Maintain product and material integrity through appropriate identification, status control, segregation, storage conditions, and handling practices.
- Support accurate inventory transactions and records in applicable systems; promptly report discrepancies, damage, excursions, or other conditions that could affect product quality or traceability.
- Follow applicable stock rotation practices, including FIFO or FEFO where required, and maintain orderly, clean, and controlled storage areas.
- Support safe warehouse practices, including proper use of equipment when trained and authorized, appropriate PPE, and timely reporting of hazards or unsafe conditions.
Process Improvement and Documentation
- Participate in Practical Process Improvement (PPI) initiatives, process mapping, cycle-time analysis, and other efforts to improve quality, efficiency, and customer service.
- Review and help improve SOPs, work instructions, forms, and process documentation in collaboration with process owners and Quality Assurance.
- Ensure records are complete, accurate, attributable, legible, contemporaneous, and maintained in accordance with data integrity and documentation requirements.
- Communicate clearly with internal teams and suppliers, manage expectations, and provide timely updates on investigations, purchasing activities, and operational issues.
Qualifications and Experience
- Experience in operations, investigations, quality systems, procurement, supply chain, warehouse operations, or a related role.
- Experience conducting or supporting root cause analysis, deviation investigations, CAPAs, change controls, or audit actions; experience in a GxP-regulated environment is preferred.
- Experience supporting purchasing activities, supplier coordination, quotation analysis, purchase order follow-up, or commercial discussions is preferred.
- Familiarity with TrackWise or another electronic quality management system is preferred.
- Strong technical writing, analytical, organizational, and documentation skills.
- Intermediate proficiency with Microsoft Office and Outlook; experience with ERP, inventory, or procurement systems is preferred.
- Intermediate English proficiency.
- Strong interpersonal and communication skills, with the ability to collaborate across functions and manage multiple priorities in a dynamic environment.
- Careful, detail-oriented, customer-focused, flexible, and willing to support changing operational needs.
- Demonstrates Thermo Fisher Scientific’s values of Integrity, Intensity, Innovation, and Involvement.
Scope of Role
This position is primarily focused on investigations, quality action management, and procurement support. Warehouse and broader operational activities are included to provide coverage and maintain continuity of operations.