Deviation Investigator II — CAPA & RCA Leader

Lonza Group Ltd.; Portsmouth (NH); Sur place; USD 80 000 - 110 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision insurance

Career development

Inclusive workplace

Performance rewards

Team-focused culture

Résumé du poste

Lonza Group Ltd. is seeking a Deviations Investigator II to lead and execute deviation investigations in a cGMP environment at our Portsmouth, NH site. The role focuses on root cause analysis, CAPA implementation, and mentoring junior investigators to enhance investigation quality.

The position emphasizes independent work, cross-functional collaboration, and maintaining compliant documentation practices in a fast-paced setting with a Monday–Friday schedule and on-site operations.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a related field; 3–5+ years in a GMP-regulated environment.
• Strong working knowledge of cGMP, GDP, and data integrity.
• Proven experience leading deviation investigations and applying RCA tools and CAPA development.
• Ability to manage multiple priorities and meet timelines in a fast-paced setting.
• Strong technical writing and cross-functional collaboration skills.

Responsabilités

• Independently lead and complete minor deviation investigations.
• Support major deviation investigations with guidance from leadership.
• Mentor Level I investigators to elevate team capability.
• Make real-time containment and investigation decisions.
• Apply RCA tools to drive thorough investigations and actionable CAPAs.

Connaissances

Root cause analysis

CAPA development

GMP knowledge

Documentation

Mentoring

Microsoft Office

Formation

Bachelor’s degree in Life Sciences/Engineering

Outils

Microsoft Office

Description du poste

Lonza Group Ltd. is seeking a Deviations Investigator II to lead and execute deviation investigations in a cGMP environment at our Portsmouth, NH site. The role focuses on root cause analysis, CAPA implementation, and mentoring junior investigators to enhance investigation quality.

The position emphasizes independent work, cross-functional collaboration, and maintaining compliant documentation practices in a fast-paced setting with a Monday–Friday schedule and on-site operations.