Quality Assurance Associate II

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

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Spring House, Pennsylvania, United States of America

Job Description:

Janssen Pharmaceuticals, Inc a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance (QA) Associate II at the Spring House, PA campus!

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 introducing new products to manufacturing and improving existing processes to help improve patient and customer care? Apply today to this exciting opportunity!

In this role, you will be providing quality oversight for daily activities related to commercial supply chain operations supporting production of commercial and clinical drug substance in the biotherapeutics product portfolio. 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.

The QA Associate II is responsible for providing Quality Assurance and Quality Oversight services to designated manufacturing sites. This role ensures the manufacturing site maintain a state of inspection readiness through internal audits and by assuring compliance with regulatory and Johnson & Johnson requirements. The associate ensures compliance with cGMPs and is responsible for performing regular scheduled oversight within manufacturing, and warehouse areas to ensure inspection readiness at all times.

Key Responsibilities:

• Provides Quality review and guidance associated with review and approve investigations and CAPAs, change controls, protocols, reports, area releases, project planning and site procedures.
• Provide quality input on a variety of compliance related issues and attend meetings as a quality representative.
• Act as Quality representative to provide on the floor QA oversight (gowning), hood requalification, and on-call quality support (rotation) in Manufacturing Operation and escalate issues to quality management for consultation.
• Partner with QA Document Control, QC, Manufacturing, Execution Systems, Plant Logistics, Validation/Compliance, and Regulatory Affairs to ensure documentation/process changes align with regulatory filings and maintain validated process.
• Increase the compliance profile by identifying gaps within processes and procedures.
• Provide support on Local and Global Change controls-related items such as providing input on the proposed change control assessor and implementation activities.
• Revise and acquire approval for departmental documents and coordinate document approvals against timelines.
• Support internal and external audits, inspections, FDA pre-inspection readiness, certifications, tracking, and trending activities.
• Support the maintenance program by reviewing, approving, and documenting within SAP, Work Orders, PM/Calibration Extensions, and PM/Calibration Change Requests.
• Work independently on routine tasks and will have support to resolve some complex technical issues.
• Ensure all non-conformances are fully investigated and effective corrective/preventive actions (CAPA) are implemented in a timely manner.
• Review and approve controlled documents including standard operating procedures, work instructions, validation protocols and reports, and technical studies.
• Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, and providing quality input on implementat