Janssen Pharmaceuticals, LLC is part of the Janssen Pharmaceutical Companies. a member of Johnson & Johnson’s Family of Companies is recruiting for a Lead Analyst QC located in Titusville, NJ.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Pharmaceuticals, LLC is part of the Janssen Pharmaceutical Companies.

This role will support stability site efforts to remain compliant with corporate and regulatory requirements. The role will lead two-three direct reports in managing investigations, CAPA’s, Change Controls, and being inspection ready at all times.

The candidate will be part of an effective team, that interacts with multifaced parts of the organization. Including, but not limited to Quality Control, Sample Management, Lab Compliance, and Lab Services.

This job provides the candidate with a wide array of experiences between the different functions and even sectors i.e Pharma and Consumer.

Key Responsibilities:

• Drives best practices and standardization of both Compliance and Quality Assurance activities
• Responsible for training new employees and providing mentorship, coaching, and support as needed
• Monitors/supervises changes in regulatory environment (e.g., compendia, regulations/directives, mentorship documents, global standards) and assures impact of the changes to Stability Operations are assessed by appropriate SME and CAPA implemented, as needed
• Interact with Health Authorities during inspections and leads discussions demonstrating a proficiency of stability quality systems, products, and technologies
• Maintains inspection readiness system and activities for the site
• Participates in quality audits, inspection activities and responses
• Draft, edit, review and approve department standard operating procedures (SOPs) and work instructions (WIs)
• Responsible for assuring compliance to all relevant regulatory requirements (e.g., global cGMPs, DEA, EH&S) is supervised and gaps are mitigated
• Coordinates, maintains, tracks, monitors, reports and drives quality metrics
• Manages timeliness of local investigations, CPA, Change Controls (e.g., supervises open records and assures closure)
• Monitors non-conformance and dedication data for trends

Qualifications

Education:

• A minimum of a Bachelor's degree

Experience and Skills:

Required:

• Experience in a regulated environment.
• Experience with an electronic Learning Management System
• Proficient in MS Office Applications (Outlook, WORD, PowerPoint, Excel, and Teams)
• Willing to be physically on-site 5 days a week.
• Familiar with good documentation practices and good lab practices.
• CAPA review board and quality system metric review

Other:

• The anticipated base pay range for the position is $88,000 to $124,000.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

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 .]