Specialist 2, Quality Systems - Training at Halozyme Therapeutics in San Diego, CA

Job description

Save time and apply through your LinkedIn account. Click the Apply with LinkedIn button and your LinkedIn profile will be imported into our site. In order to move forward, you will need to create an account. Your password must be eight characters long, contain at least one special character, one capital letter and a number. We look forward to discovering your talents. Welcome to an inspired career. At Halozyme, we are reinventing the patient experience and building the future of drug delivery. We are passionate about the important work we do and constantly strive to do more. We embrace transformation and work hard to innovate for the future. We do this together, as One Team – we rise by lifting others up and believe in the power of working together for the collective win. That’s why we need you—to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo, advancing our mission and making our One Team culture thrive. Join us as a Specialist 2, Quality Systems - Training , and you’ll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people’s lives. How you will make an impact The Specialist 2, Quality Systems - Training shall administer and maintain training, document control, and record management processes within the Quality Management System. In this role, you will maintain training administration activities in ComplianceWire and MasterControl, including training assignments, new hire training coordination, user account administration, and training record maintenance. You will also be responsible for supporting document control, records management, and ERP system activities, while supporting audit and inspection readiness through the retrieval and organization of training records, controlled documents, and supporting evidence. Additionally, you will support Quality Systems and related processes to help maintain compliant and efficient quality system operations. In this role, you’ll have the opportunity to: Administer training activities within ComplianceWire and MasterControl Training. Execute training assignments and curriculum requests submitted by departments and functional managers. Coordinate onboarding and new hire training activities to support timely completion of required training. Maintain accurate training records and training data within applicable systems. Troubleshooting training-related issues, including access, assignment, curriculum and completion record concerns. Coordinate training activities associated with document releases, revisions, and change control activities. Provide training records and supporting documentation during audits, inspections, and quality reviews. Support document control activities within the Quality Management System, including document routing, review workflows, approvals, releases, revisions and obsolescence activities. Support document-related change control activities and associated workflow tasks. Ensure controlled documents are processed in accordance with applicable procedures and regulatory requirements. Support retrieval and distribution of controlled documents during audits inspections, and business operations. Support records management activities, including storage, retrieval, archival, retention, and disposition activities. Maintain records in accordance with company procedures and applicable retention requirements. Coordinate records requests to support audits, inspections, investigations and operational needs. Collaborate cross-functionally with Quality, Operations, Engineering and other departments to support BOM and item management through ERP systems (e.g., NetSuite), MasterControl and CAD platforms. Perform duties in accordance with the Company’s Quality Management System and applicable procedures. Perform related duties as assigned. To succeed in this role, you’ll need: Minimum two years of college