Deviation Investigation Level 1 - Night Shift

Deviation Investigation Level 1 - (Night Shift)

Location: This position is based in our Portsmouth, NH office. This is a night-shift position operating on a 12-hour rotating schedule (7:00 PM - 7:00 AM). The schedule follows a rotating pattern of Monday-Tuesday workdays, Wednesday-Thursday off, Friday-Sunday workdays, and continues a biweekly rotation.

What you will get:

Below you will find a comprehensive summary of the benefits package we offer:

• 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).

Compensation for this role will be determined by the candidate's qualifications, skills, experience, and relevant knowledge.

What you will do:

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.

Key responsibilities include:

• 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

What we are looking for:

• 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); familiarity with biologics or mammalian processes is a plus

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.