Quality Assurance Associate II

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Associate II, for Quality Operations! At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Supply Group, LLC, is part of the Janssen Pharmaceutical Companies. Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity! The QA Associate II is responsible for providing quality oversight for daily activities related to the production of a variety of biologics and gene therapy products for use in commercial or clinical trials. Key Responsibilities: Provide Quality review, approval, and relevant guidance associated with investigations, documents, implemented batch records, area releases, and site procedures. Support day-to-day manufacturing operations in Quality Assurance. Maintain written records of work performed in paper-based and computerized quality systems. Drive inspection readiness activities for the site. Proactively evaluate and facilitate remediation of compliance risks and provide recommendations to site personnel. Participate in inspection activities and responses. May participate in process improvement projects including assessing current processes, providing improvement input, and working with partners to implement changes. Facilitate or participate in any and all required meetings related to quality. Conduct duties in compliance with company/site policies, standards and procedures, as well as with all local, state, and federal regulations and guidelines including FDA, EMA, EPA, and OSHA. Make a positive contribution as demonstrated by making suggestions for improvement and learning new skills, procedures, and processes. Remain current in skills and industry trends. Qualifications Education: Minimum of a Bachelor’s or equivalent University degree in Biology, Biochemistry, Microbiology, Chemistry or related field is required Experience and Skills: Required: Minimum 2 years of relevant work experience Proven organizational skills, with a high degree of accuracy and attention to detail Excellent interpersonal, written, and verbal communication skills Demonstrated positivity and capability to work in a team environment under minimal direction Preferred: Experience in Quality Assurance related to manufacturing Knowledge of cGMP regulations Experience working in an aseptic manufacturing facility Other: Requires ability to work in an aseptic processing environment (Grade B or ISO 7) and adhere to cleanroom gowning procedures Requires ability and flexibility to accommodate production schedule occasionally outside Monday-Friday 8:00AM to 4:30PM Requires up to 25% domestic travel locally to other Janssen sites in Pennsylvania At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Primary Location United States-Pennsylvania-Spring House-Welsh & McKean Roads Other Locations North America-United States-Pennsylvania-Malvern Organization JANSSEN SUPPLY GROUP, LLC (6046) Job Function Quality Requisition ID 2206051855W