Job Description

Job Title: Deviations Investigator IILocation: Portsmouth, NH (On-site)The Deviation Investigator II is responsible for leading and executing deviation investigations within a cGMP environment, with a focus on identifying root cause and implementing effective corrective and preventive actions (CAPAs). This role operates with a higher level of independence and plays a key part in mentoring junior investigators and driving investigation quality.This role follows a Monday-Friday, 8:00am – 4:30PM schedule.What you will get:An agile career and dynamic working cultureAn inclusive and ethical workplaceCompensation programs that recognize performanceMedical, dental, and vision insuranceOpportunities to grow and develop your careerA collaborative and team-focused environmentThe opportunity to support the delivery of life-changing therapiesWhat you will do:Independently lead and complete minor deviation investigationsSupport and contribute to major deviation investigations with guidance from team leadershipProvide direction and mentorship to Level I investigators, helping to elevate team capability and consistencyMake real-time decisions related to deviation containment and investigative approachUtilize a range of root cause analysis (RCA) tools (e.g., 5 Whys, fishbone, cause mapping) to drive thorough investigationsManage a moderate workload of concurrent investigations, ensuring timely and high-quality completionDrive strong documentation practices with a target of >80% Right First Time (RFT)Partner cross-functionally to gather information, resolve issues, and ensure alignmentDevelop and implement effective CAPAs to prevent recurrenceMaintain compliance with cGMP, GDP, and data integrity standardsFacilitate meetings, navigate conflict, and communicate effectively with stakeholdersPerform additional duties as assignedWhatwe are looking for:Bachelor’s degree in Life Sciences, Engineering, or a related field, with 3–5+ years of experience in a GMP-regulated environment (Quality Assurance or similar function)Strong working knowledge of cGMP, Good Documentation Practices (GDP), and data integrity principlesProven experience leading deviation investigations and applying root cause analysis tools (e.g., 5 Whys, fishbone, cause mapping) and CAPA developmentAbility to manage multiple priorities, make sound decisions, and deliver on timelines in a fast-paced environmentStrong technical writing skills and attention to detail, with a focus on compliant, high-quality documentationEffective communication and collaboration skills, with the ability to work cross-functionally and mentor junior team membersDemonstrated problem-solving ability and a proactive, solution-oriented mindsetProficiency in Microsoft Office (Excel, Word, PowerPoint); experience with biologics or mammalian processes strongly preferredAbout LonzaAt 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.SummaryLocation: US - Portsmouth, NHType: Full time

Job Tags

Similar Jobs