Quality Assurance Specialist

Job Description

1. Writing, change control, issuance, and organization of Standard Operating Procedures (SOPs).
2. Organization and control of quality, compliance, and project related documentation.
3. Lead utilization of an electronic document management system.
4. Assists with preparation of regulatory filings and supporting documentation.
5. Ensuring that quality operations are efficient, effective and meet target time frames from both a compliance and business perspective.
6. Confirm that the audit procedures are properly carried out and assigned work schedules are maintained.
7. Issuance, review, tracking, and completion of internal deviations and CAPAs.
8. Consult with quality manager and personnel on better operational procedures to improve overall efficiency.
9. Discuss system evaluation with quality manager, make appropriate recommendations and set timetable for improvement and correction.
10. Have fundamental knowledge of clinical trials.

Job Requirements

1. Bachelor of science in Chemistry/Biology/Micro Biology  
2. Ability to communicate both written and orally, to all levels of management and across different cultural backgrounds.
3. Knowledge of international regulations for quality systems and compliance.
4. Ability to identify problems, and initiate corrective actions and preventative actions.