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 Systems **Job Category:** Professional **All Job Posting Locations:** US404 PR Gurabo - Road 933, Km 0.1 **Job Description:** Janssen Ortho LLC is looking for a **Senior Quality Assurance Specialist, CSV** **(Computer System Validation)!** This position can be located in Gurabo, Puerto Rico. Dedicated to ensuring the quality and compliance of qualification documents for both computerized and non-computerized systems at our Gurabo Janssen (Innovative Medicine) Supply Chain site. This role involves overseeing the process validation of manufacturing and packaging documentation while evaluating hardware and software changes to ensure adherence to cGMP standards. _At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity._ **Position Summary:** The SR Quality Assurance Specialist CSV is responsible for ensuring the quality and compliance of qualification documents to validate various systems used on the Gurabo site, including laboratory equipment for analytical and microbiology purposes. Evaluates and assess the potential impact of process changes, specifically related to hardware and software, on the quality and/or cost of related processes and products. Ensures that all computerized and analytical systems related to cGMPs are appropriately validated and comply with federal and local agencies' rules and the policies and standards of Janssen Gurabo Site and J&J CSV (Computer System Validation). Drives the laboratory investigations and Corrective and Preventive Actions (CAPAs) within the Quality System, ensuring compliance with established company and corporate standard operating procedures, policies, rules, and regulations, as well as current GMP guidelines. **Key Responsibilities:** + .Ensure the quality and compliance of qualification documents that validate computerized and non-computerized systems used in the Janssen Supply Chain-Gurabo Site. + Evaluate, review, and approve CSV lifecycle documentation and test results for both existing and new systems, ensuring compliance with good software engineering practices and regulatory standards. + Review and approve various documentation, including SRS (Software Requirements Specifications), SDS (Software Design Specifications), FAT (Factory Acceptance Testing), SAT (Site Acceptance Testing), Unit Integration Testing, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), Release notification letters, Deviations, Code Reviews, and master plans. + Assess the potential impact of process changes, specifically related to Laboratory hardware and software, on the quality of related processes and products. + Provide support for upgrades, modifications, or changes to GxP Systems components, considering the quality and compliance perspective. + Support upgrades, modifications, or changes to GxP Systems software based on the assessment in accordance with 21 CFR Part 11. + Provide support during troubleshooting activities of laboratory computerized systems during the qualification and maintenance phases. + Ensure that all computerized, analytical, and microbiology systems maintain their validated state through conducting an annual periodic review and revalidation as required. + Develop procedures and qualification documents for Computerized Systems and the Validation of Quality Assurance (QA) systems whenever necessary. + Plan, prepare, and conduct vendor audits when necessary. + Periodically review the current procedure against the Janssen Supply Global standards. + Exercise high-level judgment in relation to laboratory systems and investigations/CAPA (Corrective and Preventive Actions). + Evaluate and approve product and laboratory events and deviations. + Evaluate and approve Corrective and Preventive Action (CAPA) records. + Monitors the performance of Investigations and Corrective and Preventive Actions (CAPAs). + Receives complaints from other J&J affiliates that are related to products manufactured at the site. + Review and approve various documents, including method transfer protocol and reports, Work Instructions (WI), Standard Operating Procedures (SOP), and Forms. + Assists with FDA and other regulatory inspections, including foreign inspections. + Develops, coordinates, and delivers compliance and general Good Manufacturing Practices (GMP) training. + Follow up and ensure the appropriate closure of any outstanding GMP issues identified during internal audits and FDA inspections. **Qualifications:** **Education:** A minimum of a Bachelors or equivalent University degree is required with a focus in Chemistry, Biochemistry, Microbiology or Biology preferred. **Required:** + Six (6) to Eight (8) years of experience in the pharmaceutical industry and knowledge of compliance with computerized systems. + Experience in the evaluation, review, and approval of all CSV life cycle documentation and test results for compliance with good software engineering and regulatory standards. **Key Skills & Knowledge:** + Facilitate negotiations between different groups to reach resolutions for complex issues. + Streamline and align existing policies and procedures. + Collaborate with the team to assess and balance risks and benefits to find optimal solutions to problems as they arise. + Read, interpret, and analyze complex documents such as policies and procedures manuals. + Make precise decisions while working at a fast pace. + Work under pressure. + Possess advanced analytical and investigative skills to evaluate the impact of CSV compliance considering the current system specifications and company policies and procedures. + Interdependent Partnering. + Customer Focus (internal customer). + Apply statistical techniques to track and analyze process performance. + Superior problem-solving and analytical skills. + Make sound business judgment. + Handle multiple tasks at the same time and efficiently interact and work with multiple processes, departments, and across GPSG sites. + Expert understanding of cGMP, Good Documentation Practices, and Regulations. + Thorough understanding of both US and international Good Manufacturing Practices (GMPs), as well as the computerized requirements applicable to the pharmaceutical industry. + Strong knowledge of US Computerized Regulatory requirements and International Regulatory Requirements. + Strong problem solving and decision-making skills related to analytical and microbiology investigations and CAPA. + Good interpersonal skills + Manage complexity and conflict. + Interpret industry guidelines as well as internal company policies to provide guidance to teams on the qualification and validation of all GMP systems and equipment. + Provide Quality Control/Quality Assurance perspective on various matters such as user requirements, quality and compliance requirements for processes and products, qualification and validation parameters, etc. Additionally, it involves aiding in the resolution of related issues. **Other:** + This position may require up to 10% domestic travel. 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 .