Job Function: Supply Chain Manufacturing
Job Sub Function: Manufacturing Pharmaceutical Process Operations
Job Category:Professional
All Job Posting Locations:Raritan, New Jersey, United States of America
Job Description:We are searching for the best talent for a Lenti Investigator to join our team in Raritan, NJ.
Summary:The Investigator will lead cross-functional investigations teams to identify true root cause of investigations, conduct risk assessments, and assess the impact of nonconformances.
Key Responsibilities:- Conduct root cause analysis investigations and author nonconformance reports.
- Coordinate discussion to identify process improvements related to safety, environmental, quality, compliance, efficiency, and yield.
- Recognize and act on potential compliance issues and opportunities for process changes/improvement.
- Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).
- Coordinate data collection and trend analysis in support of nonconformance management and/or audit activities
Qualifications:Education:- A minimum of a Bachelor's degree is required, focus degree in Engineering and/or Life Science is preferred.
Experience and Skills:Required:- Minimum 2 years of relevant work experience
- Ability to read, analyze, and interpret technical documents,SOPs, common scientific / technical journals, legal documents, and government regulations/guidance documents (EU GMPs, Annex 1, CFR, USP)
- Excellent written and oral communication skills
- Experience within cell/gene therapy, biopharmaceutical, or pharmaceutical industry
Preferred:- Experience with one or more of the following enterprise systems: eLIMS, Salesforce, Maximo, EMS, TrackWise, Veeva, and/or SAP
- Experience with internal and/or external regulatory audits/inspections
- Experience with quality investigations, including root-cause analysis of nonconformance events and familiarity with root cause analysis tools
Other:- May require up to 10% domestic travel
#LI-Hybrid
Required Skills:Preferred Skills:The anticipated base pay range for this position is :$65,000.00 - $104,650.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
• Vacation -120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
• Holiday pay, including Floating Holidays -13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave - 80 hours in a 52-week rolling period10 days
• Volunteer Leave - 32 hours per calendar year
• Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
