Sr Specialist - QA DI & CSV

Overview Join a Leader in Pharmaceutical Manufacturing — And Build What’s Next. Jubilant HollisterStier LLC is Spokane’s largest manufacturing company and a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world. We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant HollisterStier is proudly part of the global Jubilant Pharma family. For the Builders, Innovators, and Doers — This Is Your Place. If you thrive on solving complex problems, improving systems, and building real solutions, you’ll feel at home here. Your ideas matter — and your impact is felt globally. Responsibilities Provide technical expertise to define approaches and execution of computer system validation activities in accordance with cGxP, CFR Parts 11, 210 & 211, Annex 11, and other applicable regulations or procedures. Work with IT CSV and Engineering to develop and manage project documentation for SDLC requirements during computer system implementation projects, including developing user and functional requirements, technical and functional business process flows, use case, test case, and test script documents, and review and approve functionality, usability, and testing during required project phases. Review and enforce necessary improvements and corrections to established systems and processes via mitigation plans and change control. Work with project teams to select methods and techniques for obtaining desirable solutions for each project and ensure compliance with regulations. Direct the site Data Integrity program. Provide QA oversight of CSV Periodic Review program. Participate as SME in internal and external vendor audits relating to computerized systems. Keep apprised of developments in Jubilant Life Sciences’ marketplace and the challenges in the Business Units to identify potential opportunities. Qualifications Bachelor’s Degree in Computer Information Systems, Management Information Systems or related field required. Minimum of 5 years related experience in Computer System Validation required (with Bachelor’s degree). 10+ years of experience can be used in lieu of a Bachelor’s degree. FDA Regulated Industry experience required. Strong communication skills with the ability to interpret needs at the business process and technical levels. Critical problem solving skills and ability to work independently on concurrent assignments. Advanced knowledge of Microsoft Word, Excel and PowerPoint. Experience with SAP, MasterControl, Trackwise, and ComplianceWire desired. Supervisory and pharmaceutical experience desired. Physical requirements: ability to lift 20 pounds unassisted; prolonged sitting; computer use; ability to work in ambiguous and complex situations with development of new solutions. Minimal travel required. Position is on-site at least 75%. Location and Schedule Location: Spokane, WA — On Site, Hybrid at least 75% onsite Shift: Monday-Friday 8:00 AM – 5:00 PM Compensation & Benefits Hiring Wage: $89,300.00 – $142,800.00, with opportunities for growth, promotion, and annual raises. Benefits start on day one and include: Medical, Dental & Vision coverage Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA) Life & AD&D Insurance Short-Term & Long-Term Disability Insurance Employee Assistance Program Application and Equal Opportunity If you’re seeking a dynamic and rewarding career, we welcome your application today. Apply online: Careers - Jubilant HollisterStier Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. If you require assistance applying for a position, contact: View email address on click.appcast.io Our Promise: Caring, Sharing, Growing. We are committed to enhancing value for customers and stakeholders by delivering innovative and economically efficient solutions, always with care for the environment and society. #J-18808-Ljbffr