Quality Assurance Auditor, 3rd shift

Janssen Ortho LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Auditor, 3rd shift in Gurabo, PR. 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 Ortho LLC, is part of the Janssen Pharmaceutical Companies. The Quality Assurance Auditor is accountable for ensuring the compliance with all material specifications, current Good Manufacturing Practices, approved written procedures, Company Global Standards and Quality Agreements during batch record review and continuous flow processes related to the manufacturing and/or packaging of a product, comprehending raw materials, drug substances, WIPs, finished product, intermediate stages and packaging components. Responsibilities: Collaborate with Operations, Logistics, Warehouse, Technical Operations, Site Services, Quality Assurance and QC Laboratories to tackle potential compliance issues in a proactive way in order to deliver product on time. Review batch records and perform continuous flow of the WIP’s, Intermediate Stages, Finished Good and/or Raw Materials (API and Excipient) batches to ensure compliance, before a batch is released, distributed, rejected. Identify and evaluate related documentation such as Investigations (Events and Deviations), Change Controls, and Protocols, Reports, Validation documents, Forms and Cleaning Validation Notifications to resolve materials and / or product quality of a batch before conducting continuous flow into the next operational step. Assure prior that all supervised items established by current procedures, current specifications, quality agreements or customers are considered. Ensure all related samples for the specific stage have been taken and been indicated accordingly in SAP System and/or LIMS. Assure equipment cleaning at risk documentation have been accurately detailed in SAP as a flagging item for the Order Release Group. Support the Cycle time reduction in batch records review and release. Assure that products are approved on time and to minimize product back-order situations related to Product Disposition performance. Provide immediate actions and support in the timely resolution of quality and compliance matters that may include but not limited to product segregation, product recalls and product approval/rejection. Update SAP System with batch status change of a product under investigation that should not be further processed that may require physically segregation/ identification accordingly. Qualifications A bachelor’s or higher degree in science with a minimum of two (2) years of related experience in the pharmaceutical, consumer, or medical devices industry; or an associate degree in science with at least five (5) years of related experience or an associate degree with ten (10) or more years of related experience in the pharmaceutical, consumer, or medical devices industry is required. Focused degree in Microbiology, Biology, Chemistry, or related science are preferred. Certified Quality Auditor (CQA), Green Belt, Lean Manufacturing, and/or Kaizen certifications are highly preferred. Knowledge or experience in Oral Solid Dosage forms manufacturing process is required. Knowledge in documents such as safety rules, Standard Operating Procedures, Work instructions, investigations, validation reports, and protocols is required. Proficiency with Microsoft Office tools (Word, Excel, PowerPoint) is required. Knowledge in SAP, Compliance Wire, Documentation System, Investigation System (Track Wise), and/or LIMS is preferred. Proficiency in both languages English and Spanish (oral and written) is required. Availability to work the 3rd shift, including irregular shifts, weekends, overtime, and holidays is required. Must exercise judgment on the resolution of final release problems to meet company standards for quality, cost, and critical success factors. This position requires up to ten percent (10%) of domestic travel. 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-Puerto Rico-Gurabo- Organization Janssen Ortho LLC (2162) Job Function Quality Requisition ID 2206055354W