Quality Systems Training & Records Specialist

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

Benefits offered by this job

Employee Stock Purchase Program

401(k) matching

Tuition reimbursement

Job summary

Join a collaborative team focused on innovative drug delivery and patient impact. This role requires strong communication, independent work, and cross-functional collaboration across Quality, Operations, Engineering, and related departments.

Qualifications

• Minimum two years of college or work experience equivalent.
• Strong computer skills. Fluent with Microsoft Office business software and use of information databases, particularly Word, PowerPoint, and Excel.
• Experience with eQMS software for document management and training, with knowledge in ComplianceWire and/or MasterControl preferred.
• Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, directives and guidance.

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 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.

Skills

MS Office

Communication skills

Independent work

Team collaboration

Education

Some college / Associate degree

Tools

ComplianceWire

MasterControl

NetSuite

CAD platforms

Job description

Join a collaborative team focused on innovative drug delivery and patient impact. This role requires strong communication, independent work, and cross-functional collaboration across Quality, Operations, Engineering, and related departments.