Job Description

Overview:

We are seeking two experienced Quality Specialists to support a CDMO in Holly Springs, which includes Process Maintenance, Utilities, and Instrumentation. These roles will be instrumental in driving GMP compliance, managing deviations and investigations, and partnering closely with operations to ensure quality standards are upheld.

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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