Senior Deviation Investigator: RCA & CAPA Lead

Lonza; Portsmouth (NH); Sur place; Confidential; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision insurance

Opportunities to grow and develop your

Collaborative and team-focused culture

Résumé du poste

Lonza Portsmouth is seeking a Deviations Investigator II to lead deviation investigations in a cGMP environment and mentor junior staff. The role focuses on root-cause analysis and CAPA development to prevent recurrence, with strong emphasis on documentation and cross-functional collaboration.

The position requires a Bachelor's degree in Life Sciences or Engineering with 3–5+ years in GMP settings and proficiency in GDP and data integrity. On-site at Portsmouth, NH, Mon-Fri, 8:00am–4:30pm.

Qualifications

• Bachelor's degree required in Life Sciences, Engineering, or related field.
• 3–5+ years in a GMP-regulated environment (Quality Assurance or similar).
• Strong knowledge of cGMP, GDP, and data integrity principles.

Responsabilités

• Independently lead and complete minor deviation investigations.
• Support and contribute to major deviation investigations with guidance from team leadership.
• Provide direction and mentorship to Level I investigators, elevating team capability.
• Make real-time decisions related to deviation containment and investigative approach.
• Utilize RCA tools (5 Whys, fishbone, cause mapping) to drive thorough investigations.
• Manage a moderate workload of concurrent investigations with timely, high-quality completion.
• Drive documentation with a target of >80% Right First Time (RFT).
• Partner cross-functionally to gather information and resolve issues.
• Develop and implement effective CAPAs to prevent recurrence.
• Maintain compliance with cGMP, GDP, and data integrity standards.
• Facilitate meetings and communicate effectively with stakeholders.

Connaissances

Bachelors in Life Sciences/Engineering

Formation

Bachelor’s degree in Life Sciences, Engineering, or related field

Description du poste

Lonza Portsmouth is seeking a Deviations Investigator II to lead deviation investigations in a cGMP environment and mentor junior staff. The role focuses on root-cause analysis and CAPA development to prevent recurrence, with strong emphasis on documentation and cross-functional collaboration.

The position requires a Bachelor's degree in Life Sciences or Engineering with 3–5+ years in GMP settings and proficiency in GDP and data integrity. On-site at Portsmouth, NH, Mon-Fri, 8:00am–4:30pm.