Deviation Investigator I

Lonza • Portsmouth, NH

2d • Onsite

About The Position

We are seeking a detail-oriented Deviation Investigator to support deviation management and quality investigations within a GMP manufacturing environment. This role is responsible for documenting deviations, supporting investigations, and ensuring timely and accurate completion of quality records. The ideal candidate will bring strong technical writing skills, a solid understanding of GMP processes, and the ability to collaborate effectively across teams while developing investigation expertise.

Requirements

• Experience working in a cGMP-regulated environment within biotechnology, pharmaceuticals, or a related industry
• Basic understanding of deviation management, investigations, and quality systems
• Strong technical writing and documentation skills, with the ability to clearly and accurately write investigation reports
• Familiarity with root cause analysis tools and methodologies
• Ability to manage multiple tasks and meet deadlines in a structured environment
• Effective communication and collaboration skills, including the ability to receive feedback, demonstrate patience, and work constructively toward resolution of issues
• Problem-solving mindset with a willingness to learn and continuously improve investigation capabilities

Nice To Haves

• Bachelor’s degree in a scientific discipline or equivalent experience preferred

Responsibilities

• Independently complete deviation records that do not require formal investigation, ensuring accuracy and compliance with GMP standards
• Support and conduct minor deviation investigations with guidance from team leadership
• Assist in determining appropriate deviation classification, containment actions, and investigation approach
• Contribute to root cause analysis using structured tools such as 5 Whys and fishbone diagrams
• Support the development and implementation of corrective and preventive actions (CAPA) to address and prevent recurrence
• Manage assigned deviations and related activities to ensure timely completion and adherence to quality metrics
• Collaborate with cross-functional teams to gather information, facilitate discussions, and resolve issues
• Participate in team meetings and continuous improvement efforts to enhance deviation processes and investigation quality

Benefits

• Performance-related bonus
• Medical, dental and vision insurance
• 401(k) matching plan
• Life insurance, as well as short-term and long-term disability insurance
• Employee assistance programs
• Paid time off (PTO)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level