Deviation Investigator Level 2

Lonza•Portsmouth, NH

10d•Onsite

About The Position

The Deviation Investigator II leads and executes deviation investigations in a cGMP environment, identifying root causes and implementing effective corrective and preventive actions (CAPAs). The role operates with a high level of independence and helps improve investigation quality by mentoring junior investigators. It follows a Monday–Friday, 8:00 a.m.–4:30 p.m. schedule and is based on-site in Portsmouth, New Hampshire.

Requirements

Bachelor’s degree in Life Sciences, Engineering, or a related field.
3–5+ years of experience in a GMP-regulated environment, such as Quality Assurance or a similar function.
Strong working knowledge of cGMP, Good Documentation Practices (GDP), and data integrity principles.
Experience leading deviation investigations, applying root cause analysis tools, and developing CAPAs.
Ability to manage multiple priorities, make sound decisions, and meet timelines in a fast-paced environment.
Strong technical writing skills and attention to detail, with a focus on compliant, high-quality documentation.
Effective communication and collaboration skills, including the ability to work cross-functionally and mentor junior team members.
Problem-solving ability and a proactive, solution-oriented mindset.
Proficiency in Microsoft Office, including Excel, Word, and PowerPoint.

Nice To Haves

Experience with biologics or mammalian processes.

Responsibilities

Independently lead and complete minor deviation investigations.
Support major deviation investigations with guidance from team leadership.
Direct and mentor Level I investigators to improve team capability and consistency.
Make real-time decisions about deviation containment and investigative approach.
Use root cause analysis tools, including 5 Whys, fishbone, and cause mapping.
Manage a moderate workload of concurrent investigations and complete them on time and to a high standard.
Promote strong documentation practices, targeting greater than 80% Right First Time (RFT).
Collaborate cross-functionally to gather information, resolve issues, and ensure alignment.
Develop and implement CAPAs to prevent recurrence.
Maintain compliance with cGMP, Good Documentation Practices (GDP), and data integrity standards.
Facilitate meetings, navigate conflict, and communicate effectively with stakeholders.
Perform additional duties as assigned.