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Quality Specialist
Quality SpecialistInsight Global • Holly Springs, NC, United States
Quality Specialist

Quality Specialist

Insight Global • Holly Springs, NC, United States
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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.
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    Quality Specialist • Holly Springs, NC, United States

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