Senior QC Deviation Investigator — Root Cause & CAPA

Katalyst CRO; Portsmouth (NH); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking a Deviation Investigator Level III to lead investigations in a cGMP environment. The role requires strong RCA knowledge, ability to manage multiple projects, and excellent technical writing skills.

You will drive CAPA effectiveness, ensure timely resolutions, and mentor junior staff in a fast-paced setting. Ideal candidates have 5–10 years of related industry experience and a BS degree in biotechnology, biology, chemistry, or an equivalent field.

Qualifications

• BS Degree in Biotechnology, Biology, Chemistry or equivalent.
• Equivalent industry experience, 5–10 years.
• Strong written and verbal communication skills.
• Knowledge of RCA tools: Cause Mapping, Event & Casual Factor charting, 5 Why.

Responsibilities

• Share knowledge to enhance performance and build sustainable investigation teams.
• Aid in real-time decisions for deviation containment and investigative response.
• Manage moderate to high workloads with on-time delivery.
• Resume in-progress investigations with limited assistance from senior investigators.
• Provide direction on deviation approach and transfer knowledge to elevate team expertise.
• Aim for >80% Right First Time on customer deviation reviews.
• Drive effective CAPA to prevent recurrence.
• Perform investigations for complex events with leadership assistance.
• Perform other duties as assigned.

Skills

Inter-departmental collaboration

Strong written & verbal communication

Root cause analysis

Project management

Planning & organizing

Decision making

Education

BS Degree in Biotechnology/Biology/Chemistry or equivalent

Tools

Cause Mapping

Event & Casual Factor charting

5 Why

Job description

Katalyst CRO is seeking a Deviation Investigator Level III to lead investigations in a cGMP environment. The role requires strong RCA knowledge, ability to manage multiple projects, and excellent technical writing skills.

You will drive CAPA effectiveness, ensure timely resolutions, and mentor junior staff in a fast-paced setting. Ideal candidates have 5–10 years of related industry experience and a BS degree in biotechnology, biology, chemistry, or an equivalent field.