Deviation Investigator I

Responsibilities

• Independently complete deviation records that do not require formal investigation, ensuring accuracy and compliance with GMP standards
• Support and conduct minor deviation investigations with guidance from team leadership
• Assist in determining appropriate deviation classification, containment actions, and investigation approach
• Contribute to root cause analysis using structured tools such as 5 Whys and fishbone diagrams
• Support the development and implementation of corrective and preventive actions (CAPA) to address and prevent recurrence
• Manage assigned deviations and related activities to ensure timely completion and adherence to quality metrics
• Collaborate with cross-functional teams to gather information, facilitate discussions, and resolve issues
• Participate in team meetings and continuous improvement efforts to enhance deviation processes and investigation quality

Requirements

• Experience working in a cGMP-regulated environment within biotechnology, pharmaceuticals, or a related industry
• Basic understanding of deviation management, investigations, and quality systems
• Strong technical writing and documentation skills, with the ability to clearly and accurately write investigation reports
• Familiarity with root cause analysis tools and methodologies
• Ability to manage multiple tasks and meet deadlines in a structured environment
• Effective communication and collaboration skills, including the ability to receive feedback, demonstrate patience, and work constructively toward resolution of issues
• Problem-solving mindset with a willingness to learn and continuously improve investigation capabilities
• Bachelor's degree in a scientific discipline or equivalent experience preferred
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Benefits

Additional Information

Deviation Investigator I Location: This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 8:00 AM-4:30 PM EST. What you will get: Below you will find a comprehensive summary of the benefits package we offer: 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). Compensation for this role will be determined by the candidate's qualifications, skills, experience, and relevant knowledge.

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Company Intel

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