Deviation Investigation Level 1 - Night Shift

About the role

The Deviation Investigation Level 1 position is located in Portsmouth, NH, offering a night shift with a 12-hour rotating schedule (7:00 PM – 7:00 AM).

Responsibilities

• Support the investigation, documentation, and closure of minor deviations within a cGMP environment.
• Identify root causes and implement effective corrective and preventive actions (CAPAs) to prevent recurrence.
• Conduct and document minor deviation investigations with guidance from team leadership.
• Independently complete deviation records that do not require full investigations.
• Support real-time decision-making for deviation containment and response.
• Apply root cause analysis (RCA) tools (e.g., 5 Whys, fishbone diagrams) to identify underlying issues.
• Partner with cross-functional teams to gather information and support investigations.
• Aid in developing investigation strategies and contributing to team knowledge sharing.
• Manage multiple deviations simultaneously while ensuring timely completion.
• Drive high-quality documentation with a target of >80% Right First Time (RFT) deviation reviews.
• Support the development and implementation of effective CAPAs.
• Maintain compliance with cGMP, GDP, and data integrity standards.
• Demonstrate strong communication, collaboration, and conflict resolution skills.
• Perform additional duties as assigned.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related field, with 1–3+ years of experience in a GMP-regulated environment (Quality Assurance or similar function).
• Foundational knowledge of cGMP, Good Documentation Practices (GDP), and data integrity principles.
• Strong attention to detail with the ability to identify discrepancies and ensure compliant, accurate documentation.
• Experience or exposure to deviation investigations, root cause analysis (e.g., 5 Whys, fishbone), and CAPA processes.
• Ability to manage multiple priorities, stay organized, and meet timelines in a fast-paced environment.
• Effective written and verbal communication skills, with the ability to collaborate across departments.
• Sound decision-making skills with a proactive, solution-oriented mindset.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint).
• Familiarity with biologics or mammalian processes is a plus.

Qualifications

• None specified.

Skills

• Strong attention to detail.
• Effective communication and collaboration skills.
• Proactive problem-solving abilities.
• Microsoft Office proficiency.
• Knowledge of cGMP, GDP, and data integrity principles.
• Experience with deviation investigations, root cause analysis, and CAPA processes.

Benefits

• Performance-related bonus.
• Medical, dental, and vision insurance.
• 401(k) matching plan.
• Life insurance, short-term and long-term disability insurance.
• Employee assistance programs.
• Paid time off (PTO).

Pay

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

Schedule

This position operates on a 12-hour rotating schedule (7:00 PM – 7:00 AM) with a biweekly rotation of Monday–Tuesday workdays, Wednesday–Thursday off, Friday–Sunday workdays.