Lonza
Deviation Investigation Level 3 - Day Shift
US - Portsmouth, NH
Sponsorship not specifiedDetected 27 days ago
ExcelGMPCommunicationCollaborationMentoringWritingMicrosoft Office
About the role
- Deviation Investigation Level 3 - (Day Shift) Location: This position is based in our Portsmouth, NH office.
- This is a 1st-S hift position operating on a 12-hour rotating schedule (7:00 AM - 7:00 PM).
- The schedule follows a rotating pattern of Monday-Tuesday workdays, Wednesday-Thursday off, Friday-Sunday workdays, and continues a biweekly rotation.
Responsibilities
- Lead and independently execute complex and high-impact deviation investigations
- Mentor and support Level I and II investigators, building team capability and consistency
- Apply advanced root cause analysis (RCA) tools (e.g., 5 Whys, fishbone, cause mapping) to drive thorough and effective investigations
- Manage moderate to high volumes of concurrent investigations with consistent on-time delivery
- Drive high-quality documentation and maintain a target of >80% Right First Time (RFT)
- Partner cross-functionally to resolve complex issues and influence outcomes
- Share knowledge and best practices to strengthen investigation performance and build sustainable, high-performing teams
- Maintain strict adherence to cGMP, GDP, and data integrity standards
- Perform additional duties as assigned
- Demonstrated expertise leading complex deviation investigations and developing effective CAPAs
Requirements
- Bachelor's degree in Life Sciences, Engineering, or a related field, with 5-7+ years of experience in a GMP-regulated environment (Quality Assurance or similar function)
- Deep knowledge of cGMP, Good Documentation Practices (GDP), and data integrity principles
- Advanced proficiency with root cause analysis tools (e.g., 5 Whys, fishbone, cause mapping) and ability to coach others in their use
Nice to have
- Proficiency in Microsoft Office (Excel, Word, PowerPoint)
- experience with biologics or mammalian manufacturing 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.
This listing is sourced directly from Lonza's careers page and normalized into a canonical job model.