Quality Assurance Specialist (Holly Springs)Insight Global • Holly Springs, NC, US
Quality Assurance Specialist (Holly Springs)
Insight Global • Holly Springs, NC, US
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job_description.job_card.job_description35 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. 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.
Key Responsibilities :
- Lead and document deviations, investigations, and CAPAs within GMP-regulated environments, specifically supporting TOS functions.
- 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 :
Preferred Skills :
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Quality Assurance Specialist • Holly Springs, NC, US
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