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**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:
**About Innovative Medicine **
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Janssen Pharmaceuticals, Inc., part of the Johnson & Johnson Family of Companies, is recruiting for a Investigator – Lenti, located 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. 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.
Key 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.
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 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
Preferred:
- 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
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Agile Manufacturing, Analytical Reasoning, Analytics Dashboards, Business Behavior, Chemistry, Manufacturing, and Control (CMC), Communication, Data Analysis, Data Compilation, Data Savvy, Execution Focus, Gap Analysis, Good Manufacturing Practices (GMP), Manufacturing Standards, Operational Excellence, Plant Operations, Process Optimization, Project Administration, Technical Credibility
The anticipated base pay range for this position is :
$65,000.00 - $104,650.00
Additional Description for Pay Transparency: