Lonza
Deviation Investigation Level 2 - Night Shift
US - Portsmouth, NH
Sponsorship not specifiedDetected 23 days ago
ExcelGMPLeadershipCommunicationCollaborationProblem SolvingMentoringWritingMicrosoft Office
About the role
- Deviation Investigation Level 2 - (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.
Responsibilities
- Independently lead and complete minor deviation investigations
- Support and contribute to major deviation investigations with guidance from team leadership
- Utilize a range of root cause analysis (RCA) tools (e.g., 5 Whys, fishbone, cause mapping) to drive thorough investigations
- Manage a moderate workload of concurrent investigations, ensuring timely and high-quality completion
- Drive strong documentation practices with a target of >80% Right First Time (RFT)
- Partner cross-functionally to gather information, resolve issues, and ensure alignment
- Develop and implement effective CAPAs to prevent recurrence
- Maintain compliance with cGMP, GDP, and data integrity standards
- Perform additional duties as assigned
- Ability to manage multiple priorities, make sound decisions, and deliver on timelines in a fast-paced environment
Requirements
- 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 principles
- Proven experience leading deviation investigations and applying root cause analysis tools (e.g., 5 Whys, fishbone, cause mapping) and CAPA development
- Effective communication and collaboration skills, with the ability to work cross-functionally and mentor junior team members
Nice to have
- Proficiency in Microsoft Office (Excel, Word, PowerPoint)
- experience with biologics or mammalian processes strongly preferred
Compensation
- Compensation for this role will be determined by the candidate's qualifications, skills, experience, and relevant knowledge.
Benefits
- Performance-related bonus.
- Medical, dental and vision insurance.
- Life insurance, as well as short-term and long-term disability insurance.
- Paid time off (PTO).
Company info
- What we are looking for:
- 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.
This listing is sourced directly from Lonza's careers page and normalized into a canonical job model.