Description
The Associate Site Investigation Specialist is responsible for identifying and analysing non-conformances to determine their root causes and develop corrective and preventive actions (CAPA) in alignment with GSK Global Standards.
Key Responsibilities:
- Serve as the Lead Investigator for deviations using standardised processes and GSK Orange Belt Training and Certification program
- Utilise DMAIC problem-solving and GSK Production System (GPS) tools to improve efficiency and prevent non-compliance events
- Conduct thorough investigations of deviations and quality events
- Identify root causes and implement effective CAPAs
- Collaborate with cross-functional teams to gather information and support CAPAs
- Prepare comprehensive investigation reports documenting findings and CAPAs
- Provide training and support for effective system utilisation
- Adhere to ALCOA principles for documentation tasks
- Own deviation and environmental monitoring investigations and CAPA management
Basic Qualifications:
- Bachelor of Arts or Bachelor of Science
- 1+ years of experience in a GMP-regulated manufacturing environment or related industry
Preferred Qualifications:
- Bachelors of Science, Engineering or Biotechnology
- Orange Belt Certification
Work Arrangements: This role is 5 days on-site at a GSK manufacturing or laboratory site in the United States.
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