Quality Systems Training Specialist II

Halozyme,-Inc.-1; San Diego (CA); On-site; USD 78,000 - 109,000; Full time

Job summary

Halozyme, Inc. is seeking a Specialist 2, Quality Systems - Training to administer training in ComplianceWire and MasterControl, manage training records, and support document control within the QMS.

The role partners with Quality, Operations, and Engineering to ensure audit readiness and regulatory compliance. Responsibilities include onboarding, record maintenance, change control coordination, and ERP/CAD platform support (NetSuite, CAD).

Qualifications

• Minimum two years of college or work experience equivalent.
• 2+ years in training administration and/or LMS with document control and records management experience in regulated environments.
• An equivalent combination of experience and education may be considered.
• Strong computer skills; proficient with Word, PowerPoint and Excel.
• Experience with eQMS for document management and training; knowledge of ComplianceWire/MasterControl preferred.
• Knowledge of GMP, ISO, QSR and related regulations and guidance.
• Excellent written and oral communication; ability to manage multiple tasks and meet deadlines.

Responsibilities

• Administer training activities within ComplianceWire and MasterControl.
• Execute training assignments and onboarding to ensure timely completion.
• Maintain accurate training records and data in applicable systems.
• Troubleshoot training issues including access, assignments and completions.
• Coordinate training tied to document releases, revisions and change control.
• Provide training records for audits, inspections and quality reviews.
• Support document control within the QMS, including routing, reviews and approvals.
• Assist records management: storage, retrieval, retention and disposition.
• Collaborate with Quality, Operations, Engineering and others to support ERP and CAD platforms (NetSuite, CAD, MasterControl).
• Perform duties per the QMS and related procedures.

Skills

Training administration

Learning management systems

Documentation management

Records management

Quality systems

Microsoft Office proficiency

Communication skills

Project management

Education

Two years college or equivalent

Tools

ComplianceWire

MasterControl

NetSuite ERP

CAD platforms

Microsoft Office Suite

Job description

Halozyme, Inc. is seeking a Specialist 2, Quality Systems - Training to administer training in ComplianceWire and MasterControl, manage training records, and support document control within the QMS.

The role partners with Quality, Operations, and Engineering to ensure audit readiness and regulatory compliance. Responsibilities include onboarding, record maintenance, change control coordination, and ERP/CAD platform support (NetSuite, CAD).