Insight Global is seeking a Quality Investigator for a large biopharmaceutical company in Holly Springs, NC. This position will be working specifically to investigate deviations for utilities, production maintenance, and instrumentation.
Key Responsibilities :
- Lead and document deviations, investigations, and CAPAs within GMP-regulated environments.
- Act as the primary Quality representative for CMRs (Change Management Requests) and TrackWise investigations.
- Provide technical writing support for detailed investigations and root cause analyses (e.g., 5 Whys, Fishbone diagrams).
- Collaborate with operations to assess GMP issues and determine appropriate quality actions.
- Challenge existing processes and contribute to continuous improvement initiatives (e.g., 5S).
- Maintain and review GMP documentation related to instrumentation, equipment, and utilities.
- Support CMMS-related quality activities and ensure compliance with internal procedures.
- Help reduce the burden on managers by owning deviation workflows and TrackWise entries.
Qualifications :
3–5 years of experience in a GMP-regulated pharmaceutical or biotech environment.Strong working knowledge of GMP principles , documentation practices, and compliance standards.Experience with TrackWise or similar deviation / compliance management systems.Proven ability to write clear, concise, and technically sound investigations.Familiarity with CMMS systems and equipment / instrumentation documentation.Ability to work independently and partner effectively with cross-functional teams.Strong attention to detail and organizational skills.Preferred Skills :
Experience supporting technical departments such as maintenance, utilities, or instrumentation.Knowledge of root cause analysis tools (e.g., Fishbone, 5 Whys).Ability to assess and challenge processes to drive quality improvements.