Job Description

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 39,000 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. Were looking for people who are determined to make life better for people around the world.

Organization Overview:
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 thorough investigations and identification of root cause and corrective/preventive action needed to prevent recurrence. The Root Cause Investigator also serves as a mentor to the functional area Lead Investigators. As such, the Root Cause Investigator plays a key role in the sites continuous improvement efforts in order to ensure the safe and continuous supply of high quality medicine.

Responsibilities:

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 Whys, 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. Monitor and ensure the health of the sites Deviation Management System by participating in metrics reviews, Management Reviews, etc.

4. 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.

5. 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.

6. Maintain current awareness of regulations, industry trends, and regulatory agency interpretation of GMP Deviation Management System requirements.

7. Maintain and build investigation skills through ongoing training and education. Participate in inspection readiness activities and support regulatory inspections by discussing investigations as required with regulatory agencies.

8. Support and abide by applicable Lilly policies as indicated in the Lilly Red Book and other company policies and procedures. All corporate compliance training requirements must be met as required and defined.

Basic Requirements:

* Bachelors degree or higher in the sciences, engineering, or related field. Candidates with no degree and 10+ years of experience in various functions supporting GMP will also be considered.
* Strong knowledge of GMP and quality systems with a minimum of 3 years of experience in manufacturing and laboratory operations. Experience within the Biopharmaceutical industry is preferred.
* 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 minimal 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 minimal supervision.
* Proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint), TrackWise (preferred).

Additional Skills/Preferences:

* 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.
* Demonstrated learning agility, and ability to think creatively, try new ideas and apply learnings.
* 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.

Additional Information:

* Travel 5%
* Position location in Branchburg, NJ

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively Lilly) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.