Specialist 2, Quality Systems - Training

Halozyme • San Diego, CA

4h

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 manages training administration in ComplianceWire and MasterControl, including training assignments, new-hire training coordination, user accounts, and training records. It 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 position supports Quality Systems and related processes to help maintain compliant and efficient quality system operations.

The role collaborates with Quality, Operations, Engineering, and other departments on BOM and item management through ERP systems such as NetSuite, MasterControl, and CAD platforms. Duties are performed in accordance with the Company's Quality Management System and applicable procedures; other related duties may be assigned. Travel may be required up to 5% of the time.

Requirements

• Minimum two years of college or equivalent work experience.
• At least 2 years supporting training administration and/or learning management systems, with experience in document control, records management, or quality systems in a regulated medical device, pharmaceutical, biotechnology, or related environment.
• An equivalent combination of experience and education may be considered.
• Strong computer skills.
• 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 drive tasks to completion.
• Ability to prioritize workload to meet deadlines while maintaining 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 is preferred.

Responsibilities

• Administer training activities in ComplianceWire and MasterControl Training.
• Execute training assignments and curriculum requests submitted by departments and functional managers.
• Coordinate onboarding and new-hire training to support timely completion of required training.
• Maintain accurate training records and data in applicable systems.
• Troubleshoot training-related access, assignment, curriculum, and completion-record issues.
• Coordinate training activities associated with document releases, revisions, and change control.
• Provide training records and supporting documentation during audits, inspections, and quality reviews.
• Support document control activities, including document routing, review workflows, approvals, releases, revisions, and obsolescence.
• Support document-related change control activities and workflow tasks.
• Process controlled documents in accordance with applicable procedures and regulatory requirements.
• Retrieve and distribute controlled documents for audits, inspections, and business operations.
• Support records storage, retrieval, archival, retention, and disposition activities.
• Maintain records in accordance with company procedures and applicable retention requirements.
• Coordinate records requests for audits, inspections, investigations, and operational needs.
• Collaborate cross-functionally 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 through in-house learning, development, and progression programs.
• Tuition reimbursement.
• Potential bonuses, sales incentives, and equity awards as part of total compensation.

What This Job Offers

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