Lead Investigator — Root Cause & Compliance Excellence

Resilience; Port Union (OH); On-site; USD 80,000 - 117,500; Full time

Benefits offered by this job

Annual cash bonus

401(k) with company match

Health care benefits

Paid vacation and holidays

Job summary

Resilience seeks a Senior Specialist, Lead Investigator to drive investigations from scope to closure, ensuring timely, compliant outcomes. You will lead root-cause analyses, document findings, and propose corrective actions to prevent recurrence.

The role emphasizes collaboration across manufacturing, quality and engineering to strengthen process robustness. The ideal candidate has extensive experience in pharmaceutical manufacturing investigations, strong documentation skills, and the ability

Qualifications

• Experience conducting regulated investigations in pharmaceutical manufacturing.
• Familiarity with cGMP documentation practices and regulatory requirements.
• Ability to present findings clearly and concisely to diverse audiences.

Responsibilities

• Lead investigations with defined scope, strategy and timeline; document progress.
• Draft investigative reports detailing scope, product impact, root cause, and corrective actions.
• Utilize approved investigation tools to drive root cause analysis.
• Collaborate cross-functionally to determine communication strategy, problem statements, action plans and CAPA.

Skills

Investigations

cGMP knowledge

Documentation

Cross-functional collaboration

Project management

Education

Bachelor's degree in Science/Engineering

Job description

Resilience seeks a Senior Specialist, Lead Investigator to drive investigations from scope to closure, ensuring timely, compliant outcomes. You will lead root-cause analyses, document findings, and propose corrective actions to prevent recurrence.

The role emphasizes collaboration across manufacturing, quality and engineering to strengthen process robustness. The ideal candidate has extensive experience in pharmaceutical manufacturing investigations, strong documentation skills, and the ability