QA Sr. Specialist - EQ AT (1 Of 2)

Janssen Pharmaceuticals, a member of Johnson & Johnson's Family of Companies, is recruiting for an QA Sr. Specialist - EQ AT either in Horsham, PA or Raritan, NJ!

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/.

This position will provide QA technical support for External Manufacturers (EM) in the Americas. 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

• Providing QA support for technology transfer project

• 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.

• Travel to the EM site to provide on-site GMP oversight and support as needed.

• Providing support to manufacturing / logistics organizations regarding aspects of GMP compliance associated with technology transfer and manufacturing.

• Remaining current with FDA and local regulations, guidelines, and quality practices associated with the pharmaceutical industry is required

• Computer proficiency in Microsoft Office tools with the ability to communicate effectively electronically.

• Continued development of knowledge and expertise as needed in order to perform job duties.