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 Assurance **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 **We are searching for the best talent for Quality Assurance Auditor- Parenterals (Third Shift) to be located in Gurabo, PR.** As the QA Auditor, you will be accountable for ensuring the compliance with material specifications, current Good Manufacturing Practices, written procedures, Company Global Standards and Quality Agreements during batch record review related to the manufacturing and/or packaging of a product, comprehending raw materials, drug substances, finished product, and packaging components for Parenteral-Large Molecules Area. **Key Responsibilities:** + Collaborate with Operations, Logistics, Warehouse, Technical Operations, Site Services, Quality Assurance and QC Laboratories to address potential compliance issues in a proactive way in order to deliver product on time. Make the appropriate recommendations and decisions to prevent process and/or product deviations. + Perform and document Process and Facility Quality Audit in a Parenteral Manufacturing and Utility Areas according to established Procedures, cGMP and J&J Standards. + Assure, prior conducting certification of a batch, that all regulated items established by current procedures, current specifications, quality agreements or customers are considered. Ensure all related documentation and samples for the specific stage have been taken and been indicated accordingly in Batch record documentation. + Coordinate and conduct AQL Inspection to finish Parenteral Products and oversight the inspection of materials and products to ensure finished product quality. + Support the cycle time reduction in batch records review and release. Assure that products are approved on time and to minimize product backorder situations related to Product Disposition performance and to optimize quality oversight and production activities. + Provides compliance support to Manufacturing and Packaging Operations to assure execution in compliance with cGMPs, Company J&J Global Standards, Company Policies, Quality Agreements, Batch Records, current specifications and current procedures. + Provide immediate actions and support in the timely resolution of quality and compliance matters that may include product segregation, product recalls and product approval/rejection. + Perform SAP transactions to ensure good Inventory practices of Parenteral Manufacturing Materials according to the established standards. **Qualifications** **Education:** + A minimum of Bachelor's degree is required. Focused degree in Microbiology, Biology, Chemistry or related science is preferred **Experience and Skills:** **Required:** + At least 2 years of overall work experience + Knowledge in documents such as safety rules, Standard Operating Procedures, Work instructions, investigations, validation reports, and protocols + Proficiency with Microsoft Office tools (Word, Excel, PowerPoint) + Must exercise judgment on the resolution of final release problems to meet company standards for quality, cost and critical success factors. **Preferred:** + Knowledge or experience in Parenteral manufacturing process + Knowledge in current systems such as but not limited to SAP, Compliance Wire, Documentation System, Investigation System (Track Wise), LIMS + Certified Quality Auditor (CQA), Green Belt, Lean Manufacturing, and/or Kaizen certifications **Other:** + Proficiency in both languages English and Spanish (oral and written) is required. + This position requires availability for working the **third shift** , including irregular (non-standard) shifts and weekends. + Ability to travel domestic up to 10% of the time 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, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. \#LI-Onsite