Quality Assurance Associate III - Malvern, United States - Johnson & Johnson

Description

Janssen Pharmaceuticals, Inc a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance (QA) Associate III located in Malvern, PA

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

In this role, you will be responsible for providing quality oversight for technology transfer and new product introductions related to the production of large molecule biotherapeutic products for use in clinical trials in a controlled cGMP environment. You will serve as the QA point of contact for various transfers identifying risks and communicating to the broader Quality teams required activities and timelines. You will act as a liaison with other internal quality organizations to standardize policies, practices, and procedures to increase quality and compliance and champion increased awareness of quality related concerns.

Key Responsibilities:

• Partner with Research & Development and GMP Operations teams to successfully transfer large molecule products and processes into the cGMP facility.
• Provide QA support for routine validation maintenance programs and project related changes.
• Review and approve controlled documents including standard operating procedures, master batch records, work instructions, controlled drawings, validation protocols and reports, and technical studies.
• Provide quality oversight of the maintenance program, including facility change requests, calibrations, corrective and preventative maintenance.
• Support change management processes including formal change controls by evaluating the proposed changes, documenting impact assessments, and providing feedback on implementation plans.
• Participate in process improvement activities including assessing current processes, providing improvement input and working with partners to implement changes.
• Support site inspections and inspection readiness.
• Other duties may be assigned as necessary.