Senior GMP Deviation Investigator

Katalyst CRO; Portsmouth (NH); On-site; USD 85,000 - 125,000; Full time

Job summary

The Deviation Investigator Level III at Katalyst CRO is responsible for investigating deviations, identifying root causes, and implementing corrective actions to prevent recurrence within a cGMP environment. The role requires working knowledge of mammalian manufacturing processes, strong technical writing, and the ability to manage multiple projects concurrently.

Ideal candidates will have 5–10 years of industry experience, excellent cross-functional collaboration skills, and a proven track

Qualifications

• BS degree in Biotechnology, Biology, Chemistry or equivalent.
• Equivalent industry experience, 5–10 years.

Responsibilities

• Share knowledge to enhance performance with the long term view of sustainable investigation teams.
• Draws from relevant experience to aid in real-time decisions for deviation containment and investigative response.
• Ability to manage moderate to high workloads with consistent on-time delivery.
• Ability to resume in-progress investigations with limited assistance from Sr. level investigators.
• Provide direction on deviation approach for investigators and transfer knowledge to personnel involved to elevate expertise.
• Work to achieve >80% Right First Time on customer deviation reviews.
• Drive for effective CAPA such that deviations do not recur.
• Perform investigations for complex events with assistance from team leadership (as needed).
• Perform other duties as assigned.

Skills

Ability to work inter-departmentally

High level operations skills

EPS behaviors (3-way communication)

Strong written/verbal communication

RCA tools: 5 Why, Cause Mapping, etc.

Planning, Organizing, Controlling

Decision making across factors

Education

BS Degree (Biotechnology/Biology/Chemistry or equivalent)

Equivalent industry experience, 5–10 years

Job description

The Deviation Investigator Level III at Katalyst CRO is responsible for investigating deviations, identifying root causes, and implementing corrective actions to prevent recurrence within a cGMP environment. The role requires working knowledge of mammalian manufacturing processes, strong technical writing, and the ability to manage multiple projects concurrently.

Ideal candidates will have 5–10 years of industry experience, excellent cross-functional collaboration skills, and a proven track