Deviation Investigation Level 1 - Day Shift

Lonza • Portsmouth, NH

5d • Onsite

About The Position

The Deviation Investigator I is responsible for supporting the investigation, documentation, and closure of minor deviations within a cGMP environment. This role focuses on identifying root causes and implementing effective corrective and preventive actions (CAPAs) to prevent recurrence.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related field, with 1–3+ years of experience in a GMP-regulated environment (Quality Assurance or similar function)
• Foundational knowledge of cGMP, Good Documentation Practices (GDP), and data integrity principles
• Strong attention to detail with the ability to identify discrepancies and ensure compliant, accurate documentation
• Experience or exposure to deviation investigations, root cause analysis (e.g., 5 Whys, fishbone), and CAPA processes
• Ability to manage multiple priorities, stay organized, and meet timelines in a fast-paced environment
• Effective written and verbal communication skills, with the ability to collaborate across departments
• Sound decision-making skills with a proactive, solution-oriented mindset
• Proficiency in Microsoft Office (Excel, Word, PowerPoint)

Nice To Haves

• Familiarity with biologics or mammalian processes is a plus

Responsibilities

• Conduct and document minor deviation investigations with guidance from team leadership
• Independently complete deviation records that do not require full investigations
• Support real-time decision-making for deviation containment and response
• Apply root cause analysis (RCA) tools (e.g., 5 Whys, fishbone diagrams) to identify underlying issues
• Partner with cross-functional teams to gather information and support investigations
• Assist in developing investigation strategies and contribute to team knowledge sharing
• Manage multiple deviations simultaneously while ensuring timely completion
• Drive high-quality documentation with a target of >80% Right First Time (RFT) deviation reviews
• Support the development and implementation of effective CAPAs
• Maintain compliance with cGMP, GDP, and data integrity standards
• Demonstrate strong communication, collaboration, and conflict resolution skills
• Perform additional duties as assigned

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