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:** R&D/Scientific Quality **Job Category:** Professional **All Job Posting Locations:** Gurabo, Puerto Rico, United States of America **Job Description:** **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 Janssen Ortho LLC part of Johnson & Johnson Family of Companies, is recruiting for a **Quality Control Sr Scientist Microbiology Laboratory** to be located in Gurabo, Puerto Rico. **Key Responsibilities:** + Performs, evaluate (trending analysis, methods validations and special studies) of Microbiology Laboratory. + Performs failure investigations to ensure compliance with laboratory processes and/or investigations to rule out laboratory errors. + Performs data entry of results and approves analysis in eLIMS. + Performs laboratory Risk Assessments require to ensure compliance with procedures and regulatory agencies. + Provide support to the microbiological aspects of the manufacture, validations and projects related to the Non Sterile Operation area. + Support tests such as Bacterial Endotoxin Tests (finished product, raw materials, Purified water and Clean Steam), Bioburden and in process product tests, Sterility tests, Biological Indicators (BIs) testing, Environmental Monitoring of aseptic manufacturing areas, isolates identification (IDs). + Support equipment qualification activities and new technology introduction. + Provide technical knowledge to make decisions related to product quality from the microbiological standpoint during aseptic or non-sterile processes and media fills as needed. + Assure the compliance to all quality control policies, procedures, and systems to ensure the timely release of high-quality products of the supply chain process. + Support Aseptic processing and Non-Sterile investigations as SME (Subject Matter Expert). + Develop and present metrics to support manufacturing microbiological data evaluation and trending. + Participate in external and internal cGMP audits. + Support laboratory projects to assure compliance, costs reduction, laboratory operations efficiency and capacity's increase. + Perform peer review of laboratory tests and environmental monitoring data as needed. + Verifies and approves documentation generated by Laboratory Analysts. + Manage the Contamination Control Strategy in collaboration with Microbiology Management **Qualifications:** + A minimum of a Bachelor of Science is required, a minor in Microbiology, Biology or Biotechnology is preferred. + Proven experience in Quality Control is required. + A minimum of four (4) years of Microbiology Laboratory GMP environment is required. + Working experience in Aseptic and Non-Sterile operations is preferred. + Experience with MS Office (Word, Excel, PowerPoint, Minitab) and in laboratory data entry systems (e.g. eLIMS) is preferred. + Knowledge in method validations and transfers required. + Familiarized with US and International GMPs and requirements for pharmaceuticals is required. + Understanding of USP, EP, JP, Annex and FDA and International Regulatory Requirements. + Fluent in Spanish & English (writing and speaking). + Flexibility to work on weekends and during irregular hours. 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 contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.