Job Description

About the Company

We’re seeking an experienced Investigator – Exceptions / OOS Writer to support Quality operations in a regulated pharmaceutical manufacturing environment. This role is responsible for leading and authoring deviation, exception, and OOS investigations, ensuring timely, thorough, and compliant documentation in accordance with cGMP and regulatory expectations. The ideal candidate is detail-oriented, analytical, and comfortable working cross-functionally in a fast-paced quality organization.

About the Role

Location & Schedule: Raleigh, NC (on-site) Shift and overtime requirements may vary based on production and investigation needs.

Responsibilities

• Lead and author deviations, exceptions, OOS, and OOT investigations from initiation through closure
• Perform root cause analysis and define effective CAPAs
• Ensure investigations are thorough, scientifically sound, and inspection-ready
• Collaborate with QC, Manufacturing, Engineering, and Quality teams to gather data and drive resolution
• Review and assess impact to product quality, regulatory compliance, and patient safety
• Support audit readiness and respond to internal and external audit inquiries
• Identify trends and support continuous improvement initiatives
• Maintain accurate, timely documentation in quality systems

Qualifications

• Education: Bachelor’s degree in Chemistry, Biology, Engineering, or related scientific discipline
• Experience: 3+ years of experience in deviation/OOS investigations in an FDA-regulated pharmaceutical manufacturing environment

Required Skills

• Strong knowledge of cGMPs, FDA regulations, and quality systems
• Proven root cause analysis and technical writing skills
• Ability to manage multiple investigations with competing priorities
• Strong attention to detail and critical thinking capabilities
• Effective written and verbal communication skills

Preferred Skills

• Hands-on experience authoring investigations and CAPAs required

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