Investigator - Lenti

Johnson & Johnson Innovative Medicine•Raritan, NJ

10d•Onsite

About The Position

The Investigator will lead cross-functional investigations teams to identify true root cause of investigations, conduct risk assessments, and assess the impact of nonconformances. This individual will perform investigation and identify resolution for deviations and atypical events. They will recommend and coordinate implementation for corrective/preventative measures to improve compliance and ensure consistent quality standards are maintained.

Requirements

Minimum 2 years of relevant work experience
Ability to read, analyze, and interpret procedure manuals, common scientific / technical journals, basic financial reports and legal documents, general business periodicals, and government regulations
Excellent written and oral communication skills to respond to critical inquiries or complaints from managers, regulatory agencies, or members of the business community
Experience within Cell/Gene therapy, Biopharmaceutical, or Pharmaceutical industry

Nice To Haves

Experience with one or more of the following enterprise systems: eLIMS, Comet Salesforce, Maximo, EMS, BMS, and/or SAP
Experience with internal and/or external regulatory audits
Experience with quality investigations, including root-cause analysis of nonconformance events
Demonstrated ability to effectively use software applications for data entry, data analysis, word processing, presentations, and calculations

Responsibilities

Conduct root cause analysis investigations and author nonconformance reports.
Identify and implement process improvements related to safety, environmental, quality, compliance, efficiency, yield, and cost.
Recognize and act on potential compliance issues and opportunities for process changes/improvement.
Assure regulatory compliance and technical feasibility of proposed changes.
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 as requested by QA and Regulatory Affairs.