Associate Investigations Technical Specialist, Lenti

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Investigations Technical Specialist, Lenti!

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity!

The Investigations Specialist will be the primary investigator who will provide technical expertise to help identify true root cause of investigations and assess product quality impact. This individual will provide technical support for the investigation and resolution of deviations and atypical events. They will recommend, own, and implement corrective/preventative measures sought at improving compliance and reducing repeat occurrences ensuring consistent quality standards are maintained.

Key Responsibilities:

• Establish corrective actions adequately addressed root cause of NC event.
• Track deviations, events and key process parameters and provides reports to management on trending, and status as requested.
• 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.
• Partner with all Cells to implement process improvements.
• Assure regulatory compliance and technical feasibility of proposed changes.
• Serves as Subject Matter Authority (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 including the annual report required for maintenance of the Statistical Quality Control Database (SQC) and the Annual Product Review (APR).

Qualifications

Education:

• Minimum of a Bachelor’s/University or equivalent degree required; focused degree preferred in Engineering or Science fields

Experience and Skills:

Required:

• Minimum 1 years of relevant work, internship/CoOp, and/or research 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 top managers, regulatory agencies, or members of the business community

Preferred:

• Experience with quality investigations, including root-cause analysis of Non conformance events
• Experience with one or more of the following enterprise systems: eLIMS, TrackWise, Maximo, EMS, BMS, and/or SAP
• Experience with internal and/or external regulatory audits
• Demonstrated ability to effectively use software applications for data entry, data analysis, word processing, presentations, and calculations
• Experience within Cell/Gene therapy, Biopharmaceutical, or Pharmaceutical industry

Other:

• May require up to 10% domestic travel
• Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week

The anticipated base pay range for this position is $61,000 to $97,750.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Work, Personal, and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below. For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits .

This job posting is anticipated to close on March 19, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .