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We are searching for the best talent for a QA Associate III to be located in Malvern, PA and support one additional site located in Spring House, PA.

About Innovative Medicine

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. We also provide direct clinical and commercial supply chain support through release of raw materials. 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 and Warehouse.
• 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 independently and lead complex projects/issues and influence others with minimal supervision.
• Ability to be organized and capable of working in a team environment with a positive demeanor.
• A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.
• Solid understanding of cGMP regulations and FDA/EU guidance related to biologics or advanced therapies is required.
• Experience with quality support in clinical/GMP manufacturing or support of GXP laboratories preferred.
• Working knowledge of GLP regulations preferred.
• Prior supervisory experience is a plus.
• Experience working with CMMS Systems like SAP and Maximo, and electronic laboratory notebook systems (Biovia, eLIMS) preferred.
• Experience performing and leading quality risk assessments for business processes preferred.
• Experience with document reviews and regulatory inspection processes is preferred.
• Ability to prioritize daily business needs while being flexible and adaptable to frequently shifting priorities preferred.
• This position is located primarily in Malvern, PA, but will require up to 50% domestic travel to the Janssen site in Spring House, PA. Are you willing and able to meet these requirements?

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center  ([email protected]) or contact AskGS to be directed to your accommodation resource.

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