Deviation Investigation Level 3 - Night Shift
Lonza•Portsmouth, NH
•Onsite
About The Position
The Deviation Investigator III is responsible for leading complex deviation investigations and driving high-quality, compliant outcomes within a cGMP environment. This role serves as a subject matter resource for investigations, providing guidance across teams and contributing to continuous improvement of investigation processes and capabilities.
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
- Demonstrated expertise leading complex deviation investigations and developing effective CAPAs
- Advanced proficiency with root cause analysis tools (e.g., 5 Whys, fishbone, cause mapping) and ability to coach others in their use
- Strong ability to manage competing priorities, make sound, risk-based decisions, and deliver results in a fast-paced environment
- Excellent technical writing skills with a focus on clarity, compliance, and quality
- Strong communication, facilitation, and influencing skills, with experience mentoring or leading others
- Proficiency in Microsoft Office (Excel, Word, PowerPoint)
Nice To Haves
- experience with biologics or mammalian manufacturing processes strongly preferred
Responsibilities
- Lead and independently execute complex and high-impact deviation investigations
- Provide technical guidance and strategic direction on investigation approach across teams
- Mentor and support Level I and II investigators, building team capability and consistency
- Make critical, real-time decisions related to deviation containment and investigative strategy
- 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
- Take ownership of in-progress or escalated investigations with minimal oversight
- Drive high-quality documentation and maintain a target of >80% Right First Time (RFT)
- Ensure effective CAPA development and implementation to prevent recurrence
- 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
- Identify opportunities for continuous improvement in investigation processes and execution
- Maintain strict adherence to cGMP, GDP, and data integrity standards
- Perform additional duties as assigned
Benefits
- 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)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
