Experience

Synteract

• United States
• Biotechnology Research
• 100 - 200 Employee

• Quality Assurance Specialist

  • Mar 2016 - Present

  • Performs the writing and revision of Standard Operating Procedures (SOPs) and Work Instructions (WI), ensures training sessions are held on new/revised SOPs. • Ensures SOP training is documented. • Supports QA management in training of staff on new versions of controlled documents. • Provides external SOP information to sponsors or third party vendors. • Assists with issue resolution and CAPA management. Analyzes trends, recommends process improvements. • Provides oversight of QA and Risk Management plans for clinical trials; liaise with Project Management and Clinical Operations departments to ensure plans are completed and followed. • Prepares for external audits conducted by clients, potential corporate partners, or regulatory agencies. Contributes to audit responses. Performs follow up to ensure audit action items are closed. As appropriate, analyzes trends and recommends process improvement possibilities. • Coordinates and conducts periodic internal audits. Develops applicable documents and conducts audits related to training documentation, study files, TMF, Systems, or study-specific spot-check audits. • Assists with maintenance of QA Audit Plan for internal audits. • Monitors changes in federal regulations and notifies relevant departments of notable changes.