Lead Investigator & Senior Specialist – Pharma

Resilience; Kentucky; On-site; USD 80,000 - 118,000; Full time

Benefits offered by this job

Annual bonus

401(k) with company match

Health, dental, vision

Paid vacation

Tuition reimbursement

Job summary

Resilience is hiring a Senior Specialist, Lead Investigator in the United States. You will drive investigations from scope to root cause with rigorous documentation and cross-functional collaboration to prevent recurrence.

Minimum 5+ years in pharmaceutical manufacturing or regulated environments, with a science/engineering degree and strong problem-solving skills. In this role you’ll engage with multiple sites in a fast-paced, compliant setting.

Qualifications

• Experience in pharmaceutical manufacturing or regulated environments.
• Familiarity with cGMP documentation and regulatory requirements.
• Strong written, verbal and presentation skills for investigations.

Responsibilities

• Manage investigations with defined scope, strategy and timeline.
• Draft investigation reports covering scope, product impact and root cause.
• Collaborate with cross-functional teams on CAPA and effectiveness checks.
• Prioritize work and escalate issues to ensure timely closure.

Skills

Pharmaceutical manufacturing

Regulatory compliance

Investigations

Communication skills

Cross-functional collaboration

Education

Bachelor’s degree in Science or Engineering

Tools

Lean problem solving

Job description

Resilience is hiring a Senior Specialist, Lead Investigator in the United States. You will drive investigations from scope to root cause with rigorous documentation and cross-functional collaboration to prevent recurrence.

Minimum 5+ years in pharmaceutical manufacturing or regulated environments, with a science/engineering degree and strong problem-solving skills. In this role you’ll engage with multiple sites in a fast-paced, compliant setting.