Senior Investigations Lead: Root Cause & Compliance

Resilience; Olde West Chester (OH); On-site; USD 80,000 - 117,500; Full time

Benefits offered by this job

Annual bonus

401(k) with company match

Healthcare (medical, dental, vision)

Paid vacation and holidays

Job summary

Resilience is seeking a Senior Specialist, Lead Investigator to drive investigations from scope to closure in a fast-paced biomanufacturing setting. You will document root-cause, CAPA actions, and cross-functional collaboration to prevent deviations and ensure quality outcomes.

The role requires deep understanding of pharmaceutical manufacturing processes, cGMP practices, and strong communication skills to present findings clearly to stakeholders.

Qualifications

• Experience in pharmaceutical manufacturing or similar regulated industry.
• Familiarity with cGMP documentation practices and regulatory requirements.
• Ability to present findings and complex information clearly.
• Ability to manage multiple investigations with timelines.
• Excellent written, verbal, and presentation skills.
• Ability to work in fast-paced, changing environments.
• Ability to prioritize to meet deadlines.
• Ability to own issues through full investigation cycle.

Responsibilities

• Manage and execute investigations with defined scope, strategy, and timeline.
• Author investigation reports covering scope, product impact, root cause, and CAPA actions.
• Utilize approved tools to drive root cause analyses.
• Prioritize work to enable timely decisions and closure.
• Escalate issues when appropriate.
• Collaborate cross-functionally to determine communication strategy and action plan.
• Define investigation strategy, tools, and timing, and ensure timely CAPA effectiveness checks.

Skills

Investigation management

Root cause analysis

cGMP knowledge

Regulatory documentation

Written & verbal communication

Presentation skills

Lean problem-solving tools

Time management

Education

Bachelor’s degree in Science/Engineering

Tools

Lean problem-solving tools

Job description

Resilience is seeking a Senior Specialist, Lead Investigator to drive investigations from scope to closure in a fast-paced biomanufacturing setting. You will document root-cause, CAPA actions, and cross-functional collaboration to prevent deviations and ensure quality outcomes.

The role requires deep understanding of pharmaceutical manufacturing processes, cGMP practices, and strong communication skills to present findings clearly to stakeholders.