QA 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:
Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America

Job Description:

Johnson and Johnson Innovative Medicine, is recruiting for a QA Associate II! This position will be located in Malvern, PA or Spring House, PA!

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

On this team, we provide end to end quality oversight of GMP R&D laboratories responsible for analytical testing of clinical and pre-clinical products in the biotherapeutics product portfolio, equipment life-cycle management, critical reagents, and material specifications.

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.

Main responsibilities will include, but are not limited to:



* Partner with Research & Development and Supply Chain teams to support platform analytical method qualification, validation, and transfer to facilitate analysis of pre-clinical, clinical, and commercial products.


* Collaborate with business partners to support process development studies.


* Perform regularly scheduled oversight of R&D GxP laboratories.


* Review and approve raw material and critical reagent release for use across the Johnson and Johnson Innovative Medicine global network.


* Review and approve controlled documents including standard operating procedures, work instructions, validation protocols and reports, and technical studies.


* Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.


* Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, and providing quality input on implementation plans.


* Provide quality oversight of the analytical instrument lifecycle management process, including new inst...