Root Cause Investigator

2 weeks ago

Branchburg, United States Lilly Full time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The Root Cause Investigator will serve as a primary investigator for site investigations into Quality and HSE events to ensure timely and accurate completion of high quality investigations and identification of root cause, and corrective/preventive actions needed to prevent recurrence. The Root Cause Investigator also serves as a trainer and mentor to the functional area Lead Investigators. As such, the Root Cause Investigator plays a key role in the site’s continuous improvement efforts in order to ensure the safe and continuous supply of high quality medicine.

**Key Objectives/Deliverables**:
**Manage for Results /Strategic Planning**:
1. Lead investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent recurrence by:

- Lead problem solving and root cause analysis sessions
- Interact with multiple functions including, but not limited to, QA, QC, Engineering, TS/MS, Operations, HSE
- Manage highly complex and visible investigations using different root cause methodologies such as 5 Why’s, Causal Factor Charting, Human Error Checklist, Fishbone, and Fault Tree.
- Ensure effective implementation of corrective and preventive actions
- Assess effectiveness of corrective/preventive actions implemented

2. Utilize technical writing strategies to ensure content is clear, concise, and complete.

3. Conduct trending of deviations in order to identify systemic issues, timely trend investigation, and to confirm associated CAPAs are implemented and effective.

4. Monitor and ensure the health of the site’s Deviation Management System by participating in metrics reviews, Management Reviews, etc.

5. Train, coach and mentor functional area Lead Investigators in aspects of incident/observation reporting, problem solving and risk management associated with root cause investigations, investigation write-ups, development of CAPA and associated effectiveness checks.

6. Observe activities on the manufacturing floor and laboratory; engage with Process Owners to gain the process knowledge needed to deliver technically sound investigations and action plans.

7. Maintain current awareness of regulations, industry trends, and regulatory agency interpretation of GMP Deviation Management System requirements. Maintain and build investigation skills through ongoing training and education.

8. Participate in inspection readiness activities and support regulatory inspections by discussing investigations as required with regulatory agencies.

**Basic Requirements**:

- Bachelor's degree, or higher preferred, in engineering, sciences, or related field.
- Strong knowledge of GMP and quality systems with a minimum of 3 years of experience in manufacturing and laboratory operations within the Biopharmaceutical industry.

**Additional Preferences**:

- Excellent technical writing skills required.
- Requires strong skills related to coaching and mentoring others.
- Strong problem solving and analytical skills are required.
- Experience with a variety of root cause methodologies.
- Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross
- functional teams and management on recommended course of action, with mínimal assistance.
- Possess knowledge of core manufacturing principles and support systems.
- Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
- Self-driven individual that requires mínimal supervision
- Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint), Trackwise (preferred).
- Ability to build relationships across dimensions of difference, ask questions & invite others to contribute.
- Demonstrated Business Acumen.
- Speak up with ideas, concerns & to ensure safety of others.
- Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
- Demonstrated success in influencing without authority.
- Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships.
- Highly flexible, adapting to changes in priorities, requirements and processes.

**Other Information**:

- Travel required (approximately 5%).
- Lifting not required.
- Not required to be on call.
- Shift work may apply.

Lilly is an EEO/Affirmative Action Employer and does not discriminate o

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