Associate Site Investigation Specialist

Job Purpose

The Associate Site Investigation Specialist is responsible for identifying and analyzing non-conformances to determine their root causes and develop corrective and preventive actions (CAPA) in alignment with GSK Global Standards. This role is critical in ensuring product quality, patient safety, regulatory compliance, and maintaining the facility's License to Operate.

Key Responsibilities

• Serve as the Lead Investigator for deviations by utilizing the standardized processes learned and completed through the GSK Orange Belt Training and Certification program
• Utilize DMAIC problem-solving and GSK Production System (GPS) tools to improve efficiency, eliminate waste, and prevent non-compliance events
• Conduct thorough and timely investigations of deviations, non-conformances, and other quality events, ensuring all relevant information is collected and analyzed
• Utilize appropriate problem-solving tools and techniques to identify root causes and implement effective corrective and preventive actions (CAPAs)
• Collaborate with cross-functional teams such as production, quality assurance, quality control, engineering, labs, and warehouse to gather information and support the implementation of CAPAs
• Prepare comprehensive investigation reports documenting findings, root causes, and CAPAs with accuracy and compliance to regulatory and internal standards
• Serve as an expert in the Validated Quality Management System (VQMS) for tracking, managing, and documenting investigations, while providing training and support for effective system utilization
• Deliver training and guidance to personnel on investigation processes, root cause analysis techniques, and deviation management to foster a quality-focused culture
• Adhere to ALCOA principles for all documentation tasks
• Own deviation and environmental monitoring investigations, write-ups, corrective and preventive action management, impact assessments, and simple change controls

Basic Qualifications

• Bachelor of Arts or Bachelor of Science
• 1+ years of experience in a GMP-regulated manufacturing environment or related industry, with experience executing production processes, supporting manufacturing operations, adhering to quality and compliance requirements, and performing assigned technical or operational tasks

Preferred Qualifications

• Bachelors of Science, Engineering or Biotechnology
• Orange Belt Certification will be required to successfully perform the role

Work Arrangements

This role is 5 days on-site at a GSK manufacturing or laboratory site in the United States.