GMP Investigator

Katalyst CRO; Portsmouth (NH); Presencial; USD 85.000 - 125.000; Jornada completa

Descripción de la vacante

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

Formación

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

Responsabilidades

• 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.

Conocimientos

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

Educación

BS Degree (Biotechnology/Biology/Chemistry or equivalent)

Equivalent industry experience, 5–10 years

Descripción del empleo

• The Deviation Investigator Level III is responsible for the investigation and completion of deviations aimed at identification of root cause and implementation of correct actions to prevent recurrence. Level III Investigators are expected to work in a cGMP environment, have working knowledge of mammalian manufacturing processes, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented, and be compliant minded while performing investigations.

Summary

• The Deviation Investigator Level III is responsible for the investigation and completion of deviations aimed at identification of root cause and implementation of correct actions to prevent recurrence. Level III Investigators are expected to work in a cGMP environment, have working knowledge of mammalian manufacturing processes, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented, and be compliant minded while performing investigations.

Key Accountabilities

• Share knowledge to significantly enhance performance within the organization with the long term view of constructing sustainable, high performing 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 the investigators and associated investigation teams, and as this occurs, transfer knowledge to the personnel involved to elevate expertise of the teams.
• 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 and with customers
• High level of area specific operations and technical skills
• Demonstrates Error Prevention System (EPS) behaviors - e.g. 3 way communication, questioning attitude, etc.
• Strong written and verbal communication skills
• Utilizes multiple RCA tools including but not limited to Cause Mapping, Event and Casual Factor charting, and 5 Why
• Demonstrate ability for effective Planning, Organizing and Controlling competency
• Demonstrate sound decision making, considering broad scope of factors

Education and Experience:

• BS Degree(Biotechnology, Biology, Chemistry or equivalent)
• Equivalent industry experience, 5-10 years