Quality Control Senior Analyst

Janssen Supply Group, LLC., a member of Johnson & Johnson's Family of companies is recruiting for a Quality Control Senior Analyst! At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Redefining lives by finding new and better ways to prevent, intercept, treat and cure disease encourages 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 Senior Analyst Quality Control is responsible for conducting stability testing in accordance with applicable procedures, standards, and GMP regulations in a safe work environment. They may also be responsible for the support of process improvements, new technologies, automated quality systems, and the transfer of new methods. Key Responsibilities: Conduct general analytical testing of stability samples submitted to the QC laboratories on an as-needed basis Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards as needed Review statistical analysis, data trending, and reporting Contribute to improvements or support quality & compliance and/or process improvement projects related to Stability Operations Responsible for initiating Quality Issues for OOS / OOT stability issues, engaging with J&J Lead Statistical SMEs for statistical support of lab investigations and test plans, where required Complete and approve corrective and preventative actions (CAPA) as assigned, as well as independently implement and lead change control process Participate in internal / external audits and interact with Health Authorities during inspections and lead in discussions demonstrating a proficiency of lab systems, products, and technologies Qualifications Education: Minimum of a Bachelor’s Degree is required, preferably in Biology, Biochemistry, Microbiology, Chemistry or related scientific field Skills & Experience: Required: Minimum of four (4) years of relevant work experience Experience in Medical Device, Biopharmaceutical, or Pharmaceutical industry Working experience in a cGMP compliant QC laboratory or equivalent environment Experience participating in internal or external audits and/or health authority inspections Proficiency with Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) Excellent written and verbal communication skills, with demonstrated ability to work cross-functionally Preferred: Strong understanding and knowledge of current Good Manufacturing Practices (cGMP) or Good Laboratory Practices (cGLP) Knowledge of analytical techniques such as UHPLC, HPLC, GC, UV-Visible spectrophotometer, KF, FTIR, or pH meters Work experience with electronic Laboratory Inventory Management Systems (eLIMS) Technical writing experience (e.g., SOPs, Work instructions, TMD, Protocol/Validation reports) and the ability to read/interpret technical documents Experience, training, or certification with Process Excellence tools and methodologies Other: Requires up to 10% domestic travel Requires the physical ability to lift up to 20lbs, stand or sit for extended periods of time in a laboratory setting, and ability to perform visual inspections of materials (color, appearance, particles, etc.) and to document observations during laboratory testing 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 (http://www.careers.jnj.com). Primary Location United States-New Jersey-Titusville-1125 Trenton Harbourton Road Organization JANSSEN SUPPLY GROUP, LLC (6046) Job Function Quality Requisition ID 2206041113W