Root Cause Investigator

3+ years

Not Disclosed

Branchburg Township

15 June 10, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Root Cause Investigator

Location: New Brunswick, New Jersey
Employment Type: Direct Hire
Pay Rate: Dependent on Experience (DoE)
Travel: Approximately 5%
Shift Work: May apply
On-Call: Not required
Lifting: Not required

About Eli Lilly and Company:

At Lilly, we unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, we are a global healthcare leader. Our employees work to discover and deliver life-changing medicines, improve disease management, and give back to communities through philanthropy and volunteerism. We strive to put people first and are determined to make a positive impact globally.

Job Summary:

The Root Cause Investigator will be the primary investigator for site investigations into Quality and Health, Safety, and Environment (HSE) events. This role ensures timely, accurate completion of high-quality investigations, identification of root causes, and implementation of corrective and preventive actions. The investigator will also mentor functional area Lead Investigators, playing a key role in the site’s continuous improvement efforts.

Key Responsibilities:

Investigation Management:
- Lead investigations to identify root causes and implement corrective/preventive actions.
- Utilize methodologies such as 5 Why’s, Causal Factor Charting, Human Error Checklist, Fishbone, and Fault Tree.
- Interact with multiple functions, including QA, QC, Engineering, TS/MS, Operations, and HSE.
- Ensure effective implementation and assessment of corrective/preventive actions.
Technical Writing:
- Use technical writing strategies to ensure investigation content is clear, concise, and complete.
Deviation Trending:
- Conduct trending of deviations to identify systemic issues.
- Perform timely trend investigations and confirm effectiveness of CAPAs.
Deviation Management System:
- Monitor the health of the site’s Deviation Management System.
- Participate in metrics reviews and Management Reviews.
Training and Mentoring:
- Train, coach, and mentor functional area Lead Investigators.
- Provide guidance on incident/observation reporting, problem-solving, risk management, and CAPA development.
Process Engagement:
- Engage with Process Owners on the manufacturing floor and laboratory to gain necessary process knowledge.
Regulatory Awareness:
- Maintain awareness of regulations, industry trends, and regulatory agency interpretations.
- Participate in inspection readiness activities and support regulatory inspections.
Continuous Improvement:
- Identify compliance issues and support implementation of continuous improvements.
- Assist in creating and revising SOPs to reflect current practices.

Basic Requirements:

Bachelor’s degree in engineering, sciences, or a related field (higher preferred).
Minimum of 3 years of experience in manufacturing and laboratory operations within the Biopharmaceutical industry.
Strong knowledge of GMP and quality systems.
Excellent technical writing skills.
Strong problem-solving and analytical skills.
Experience with root cause methodologies.
Proficient in MS Office (Word, Excel, PowerPoint), TrackWise (preferred).
Excellent organizational, verbal, and written communication skills.
Ability to work effectively in a team-based environment.
Self-driven with minimal supervision required.

Additional Preferences:

Experience working in an international, multicultural matrix organization.
Demonstrated business acumen and learning agility.
Ability to build relationships, influence without authority, and lead by example.
Highly flexible, adapting to changes in priorities, requirements, and processes.

About ProStaff Solutions Inc:

ProStaff Solutions is committed to staffing services excellence, offering best practices for clients and employees. We aim to be the premier employment solutions provider in our communities.

Benefits:

Competitive compensation and benefits package.
Major medical coverage including dental and vision.
401k, term life, short-term and long-term disability.
Pre-paid legal and identity theft plans.
Medical and dependent FSA, HSA.
Paid time off and holidays.
Opportunities for advancement.

Equal Opportunity Employer:

Eli Lilly and Company is an EEO/Affirmative Action Employer. We do not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

If you require an accommodation for the application process, please contact Lilly Human Resources at Lilly_Recruiting_Compliance@lists.lilly.com.

Employee Resource Groups:

Our ERGs offer support networks for members and help develop future leaders. Our groups include networks for African Americans, Latinos, women, LGBTQ+ allies, veterans, and more.

For more information and to explore all opportunities, visit ProStaff Solutions.