Lead Investigator: Complex Investigations

Resilience; Kentucky; On-site; USD 90,000 - 124,000; Full time

Benefits offered by this job

Annual cash bonus

401(k) match

Healthcare (medical, dental, vision)

Paid vacation

Paid holidays

Tuition reimbursement

Caregiving support

Job summary

Resilience in Kentucky is seeking a Senior Specialist II, Lead Investigator to drive the site's most complex investigations. You will determine resources and strategy, work across functions, and ensure timely, compliant root cause analyses that prevent recurrence.

This role requires experience in pharmaceutical manufacturing, knowledge of cGMP, strong communication and report-writing skills, and the ability to lead multiple investigations in a fast-paced environment.

Qualifications

• Experience in Pharmaceutical Manufacturing and/or other regulated industry.
• Familiarity with cGMP documentation practices and applicable regulatory requirements.
• Ability to present findings, conclusions, and complex information clearly.
• Ability to manage multiple concurrent investigations and drive timely closure.

Responsibilities

• Lead complex, high-impact investigations with a defined scope, strategy, and timeline.
• Document status and progress, authors reports detailing issues, root cause, and corrective actions.
• Mentor and coach other investigators on methodology and report quality.
• Collaborate with cross-functional teams to design investigation strategy, action plans, and CAPA effectiveness checks.

Skills

Investigation management

Root cause analysis

Cross-functional collaboration

cGMP knowledge

Technical writing

Communication

Education

Bachelor's degree

Job description

Resilience in Kentucky is seeking a Senior Specialist II, Lead Investigator to drive the site's most complex investigations. You will determine resources and strategy, work across functions, and ensure timely, compliant root cause analyses that prevent recurrence.

This role requires experience in pharmaceutical manufacturing, knowledge of cGMP, strong communication and report-writing skills, and the ability to lead multiple investigations in a fast-paced environment.