Lead Investigator: Complex Investigations & CAPA

Resilience; Olde West Chester (OH); On-site; USD 90,000 - 124,000; Full time

Benefits offered by this job

Annual bonus

401(k) match

Health benefits

Paid vacation

Tuition reimbursement

Caregiving support

Job summary

Resilience is seeking a Senior Specialist II, Lead Investigator to manage the site's most complex investigations, aligning resources and timelines to drive conclusions in a compliant, cross-functional environment.

You will work independently in ambiguous situations, document findings, lead root-cause analyses, and influence stakeholders while ensuring timely CAPA development and robust investigation processes.

Qualifications

• Experience in Pharmaceutical Manufacturing or other regulated industry.
• Familiarity with cGMP documentation practices and applicable regulatory requirements.
• Ability to present findings clearly and manage multiple investigations.
• Strong written, verbal, and presentation skills.
• Ability to work in fast-paced, rapidly changing environment.
• Ability to coach others and lead cross-functional alignment on root cause and corrective-action decisions.

Responsibilities

• Investigation Management & Execution leads complex investigations with defined scope, strategy, and timeline, allocates resources and documents progress.
• Authors reports detailing investigation scope, product impact, root cause, and corrective actions to prevent recurrence.
• Mentors investigators to ensure speed and rigor across concurrent investigations.

Skills

Investigations

Root cause analysis

Cross-functional collaboration

cGMP knowledge

Documentation

Education

Bachelor’s degree in science/engineering/regulatory

Job description

Resilience is seeking a Senior Specialist II, Lead Investigator to manage the site's most complex investigations, aligning resources and timelines to drive conclusions in a compliant, cross-functional environment.

You will work independently in ambiguous situations, document findings, lead root-cause analyses, and influence stakeholders while ensuring timely CAPA development and robust investigation processes.