Quality Systems Specialist - QMS & Training

Direct Relief; Santa Barbara (CA); Hybrid; USD 70,000 - 78,000; Full time

Job summary

Direct Relief in Santa Barbara, CA is seeking a Quality Specialist to support the execution and continuous improvement of our Quality Management System (QMS). This role ensures documents, workflows, and training records are current, compliant, and user-friendly, partnering with cross-functional teams to advance quality across the organization.

You will administer QMS processes, assist with MasterControl implementations, generate quality metrics, investigate discrepancies, and support CAPAs.

Qualifications

• Bachelor's degree and 3-5 years of experience in Quality Assurance or related field.
• Experience with a Quality Management System (QMS), document control, discrepancy investigations, and training management.
• Knowledge of GDP/GMP and FDA regulatory expectations in a regulated environment.
• Strong written communication and data analysis skills.

Responsibilities

• Manage day-to-day administration and maintenance of the Quality Management System (QMS), ensuring records, workflows, and documentation remain current and compliant.
• Assist with implementation, testing, validation, and continuous improvement of automated workflows and system enhancements in MasterControl.
• Provide user support and troubleshooting for QMS processes and workflows, helping employees understand quality requirements and system functionality.
• Generate, maintain, and analyze quality metrics and dashboards to support management reviews and continuous improvement efforts.
• Collaborate with staff to investigate discrepancies, document findings, perform root cause analysis, and facilitate timely resolution of quality issues.
• Assist with identification, implementation, and verification of corrective and preventive actions (CAPAs) to address root causes and prevent recurrence.
• Coordinate training activities within the QMS, monitor completion status, maintain training records, and support training compliance requirements.

Skills

Microsoft Word

Excel

Visio

SharePoint

Power Automate

Quality data analysis

Lean Six Sigma

FDA regulations

Documentation

Education

Bachelor's degree or equivalent

Tools

MasterControl

SAP

Job description

Direct Relief in Santa Barbara, CA is seeking a Quality Specialist to support the execution and continuous improvement of our Quality Management System (QMS). This role ensures documents, workflows, and training records are current, compliant, and user-friendly, partnering with cross-functional teams to advance quality across the organization.

You will administer QMS processes, assist with MasterControl implementations, generate quality metrics, investigate discrepancies, and support CAPAs.