Job Description

Janssen Supply Group, LLC., part of the Johnson & Johnson family of companies, is recruiting for a SR Quality Assurance Specialist! This position is flexible with locations including: Europe, Canada, North America, Puerto Rico with a preference for Titusville, NJ. Remote work may be considered on a case by case basis and if approved by the business. 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 Supply Group is part of the Janssen Pharmaceutical Companies. Are you interested in joining a team that is helping improve patient and customer care and drive innovation? Apply today! This position will provide QA technical support for External Manufacturers (EM) European, Latin America or North America Region. Review and approve quality system documents including SOP, specification and manufacturing instructions. Responsible for product release, ensuring products meet cGMP, Janssen specifications and regulatory requirements. Provide QA support for technology transfer and improvement of existing manufacturing processes. Contribute to the overall development, implementation and execution of quality systems in support of to ensure complaint, product quality and product safety. Conduct investigations, perform GMP audits, collect data, analyze trends, and prepare management reports as required. Responsible for continuous improvement and risk management activities of EM. Key Responsibilities:

• Reviewing batch documentation and product release
• Conducting and participating in manufacturing investigations.
• Reviewing and approving EM deviations
• Developing corrective action plans and monitoring implementation
• Review and approve change control
• Writing and implementing of quality procedures
• Identifying and implementing continual improvements of manufacturing and quality/compliance processes
• Assess current process and systems and recommend improvements to enhance reliability and reduce cycle time
• Analyzing product quality complaints and assisting the external manufacturer to complete complaint investigation
• Participating in quality audits at external manufacturers
• Monitor quality trends, identify issues, recommend and implement appropriate actions to mitigate risk.
• Participate and support escalation process and issue management process
• Support regulatory inspections, manage JJRC reporting and monitor follow up on regulatory commitments
• Maintain Quality Agreement and specification changes.

Qualifications
Education:

• A Bachelor's or equivalent University degree is required with a focus in engineering, science or equivalent technical discipline preferred.

Experience and Skills: Required:

• Demonstrates knowledge of Quality Assurance, Quality Control and Compliance
• A minimum of 6 years relevant work experience
• Ability to provide cGMP compliance support to contract manufacturers by investigating and resolving quality issue
• Experience in applying process excellence tools and methodologies
• Proficient in written and spoken English

Preferred:

• Experience in the development, implementation, and review of SOPs for interactions with contract manufacturers
• Advanced degrees in engineering, science, or an equivalent technical
• Experience investigating customer Product Quality Complaints
• Experience in pharmaceutical / biologics manufacturing or quality environment

Other: Requires up to 30% domestic and international travel 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.]

Primary Location
United States-New Jersey-Raritan-1000 US HIghway 202
Other Locations
North America-United States-Puerto Rico, Europe/Middle East/Africa, Latin America, North America, North America-Canada
Organization
JANSSEN SUPPLY GROUP, LLC (6046)
Job Function
Quality
Requisition ID
2206061150W