Specialist 2, Quality Systems - Training

Halozyme, Inc. • San Diego, CA

1d • $78,000 - $109,200

About The Position

The Specialist 2, Quality Systems - Training administers and maintains training, document control, and records management processes within the Quality Management System. The role maintains training administration activities in ComplianceWire and MasterControl, including training assignments, new-hire training coordination, user account administration, and training record maintenance.

The position also supports document control, records management, ERP system activities, and audit and inspection readiness by retrieving and organizing training records, controlled documents, and supporting evidence. The Specialist supports Quality Systems and related processes to help maintain compliant and efficient quality system operations.

Requirements

• Minimum two years of college or equivalent work experience.
• Two or more years supporting training administration and/or learning management systems, with experience in document control, records management, or quality systems within a regulated medical device, pharmaceutical, biotechnology, or related environment.
• An equivalent combination of experience and education may be considered.
• Strong computer skills and fluency with Microsoft Office business software and information databases, particularly Microsoft Word, PowerPoint, and Excel.
• Knowledge of GMP, ISO, QSR, and other applicable international regulations, standards, directives, and guidance.
• Ability to communicate effectively, orally and in writing.
• Ability to manage multiple tasks and projects and use negotiation skills to push tasks to completion.
• Ability to prioritize workload to meet deadlines while maintaining high levels of quality and accuracy.
• Ability to work independently and in a cross-functional team environment.
• Customer-service-oriented attitude and ability to exercise sound business judgment.

Nice To Haves

• Experience with eQMS software for document management and training.
• Knowledge of ComplianceWire and/or MasterControl.

Responsibilities

• 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 in applicable systems.
• Troubleshoot 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.
• 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, MasterControl, and CAD platforms.
• Perform duties in accordance with the Company’s Quality Management System and applicable procedures.
• Perform related duties as assigned.

Benefits

• Full and comprehensive benefit program.
• Employee Stock Purchase Program.
• 401(k) matching.
• Opportunities for growth in a culture that prioritizes learning, development, and progression through in-house programs.
• Tuition reimbursement.
• Collaborative, innovative team environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree