QA Associate III

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:

We are searching for the best talent for a QA Associate III to be based in Malvern, PA with occasional travel to 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

Purpose: On this team, we provide end to end quality oversight of GMP R&D GxP laboratories responsible for analytical testing of commercial and clinical products 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.

You will be responsible for:

• 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 Janssen 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 instrument qualification, equipment releases, corrective and preventative maintenance and calibrations.

• Ensure data integrity and maintain compliance with general laboratory operations, all appropriate SOPs for laboratory work, data recording, and laboratory equipment

• Lead in process improvement activities including assessing current processes, providing improvement input and working with partners to implement changes.

• Support site inspections and inspection readiness activities. Ensure the laboratories are audit ready. Support data integrity efforts.

• Other duties may be assigned as necessary.

Qualifications/Requirements:

• A minimum of a Bachelor’s Degree is required, preferably in Engineering, Biology, Biochemistry, Microbiology, Chemistry, or relevant scientific field/equivalent technical field.

• At least 4 years of experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry, is required.

• Ability to maintain written records of work performed in paper-based and computerized quality systems.

• Ability to work independen