GMP Deviation Writer | QA Investigations | CAPA | Pharma / Biotech | eQMS | FDA

We are actively hiring a Deviation Writer / QA Investigation Specialist with strong experience in GMP pharmaceutical or biotech environments.

This role focuses on deviation investigation, root cause analysis, and CAPA documentation, ensuring compliance with cGMP, FDA, and global regulatory standards. The ideal candidate will have hands-on experience writing clear, compliant deviation reports and collaborating cross-functionally in a manufacturing setting.

Key Responsibilities

• Author, review, and finalize deviation reports in compliance with GMP/cGMP standards
• Conduct and support deviation investigations across manufacturing, packaging, and testing operations
• Perform root cause analysis using tools such as 5 Whys, Fishbone (Ishikawa), or Fault Tree Analysis
• Develop and support Corrective and Preventive Actions (CAPA)
• Ensure all documentation meets FDA, ICH, and internal quality standards
• Collaborate with QA, Manufacturing, QC, Validation, and Engineering teams
• Track deviation records to ensure timely closure and compliance
• Support audit and inspection readiness (FDA / client audits)
• Maintain Good Documentation Practices (GDP) and data integrity standards
• Contribute to continuous improvement initiatives in deviation and quality systems

Required Skills 

• GMP / cGMP compliance
• Deviation Management / Investigation Writing
• CAPA (Corrective and Preventive Actions)
• Root Cause Analysis (5 Whys, Fishbone, FTA)
• QA Documentation / Technical Writing
• FDA / ICH regulatory guidelines
• Data Integrity (ALCOA principles)
• eQMS systems (TrackWise, Veeva, MasterControl or similar)
• Pharmaceutical / Biotech Manufacturing

Preferred Skills 

• Aseptic / sterile manufacturing environment
• Biologics or drug product experience
• Risk assessment tools (FMEA)
• Experience supporting regulatory inspections or client audits
• CDMO industry experience

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field
• 2–5+ years of experience in pharmaceutical, biotech, or regulated manufacturing
• Strong analytical thinking and technical writing skills
• Ability to clearly communicate complex investigation findings

Work Details

• Location: Indiana (Onsite – 5 days/week)
• Duration: 6-month contract (potential extension)
• Industry: Pharmaceutical / Biotech