Quality Control Specialist (auditing)
based in Istanbul, Turkey
The Quality Control Specialist will audit project documentation, operations processes, and analyze and report the results in a defined frequency.
- Monitor the implementation of required processes.
- Review and evaluate the quality and effectiveness of the business operations department’s policies, procedures, and processes.
- Raise quality assurance concerns and issues immediately to appropriate parties to drive resolution.
- Support lead auditor in developing audit agendas based on risk assessment principles.
- Produce timely, detailed and technically correct reports following assessments/audits with appropriate references cited against each finding.
- Partner with the Country Manager on audit findings to ensure any identified errors are promptly and appropriately corrected, as well as any performance and/or training gaps are addressed.
- Track and report quality metrics for the department and serve as the point of contact for audit inquiries.
- Assist in conducting investigations for quality complaints and deviations.
- Advise and support the sites in devising and executing remediation actions to ensure compliance to regulatory and AUD expectations and requirements.
- Regularly review corrective actions and preventive actions’ progress & effectiveness, and continue to give on-going support in all quality matters.
- Provides constructive feedback to peers and managers to promote quality culture.
- Monitor processes to identify opportunities for continuous improvement.
- Ensure all equipment is in compliance with calibration frequency.
- Ensure temperature controlled units are monitored and logged according to policies and procedures.
- Perform other related duties as assigned
- Strong English speaking and writing
- Bachelor’s Degree
- 1-2 years job related experience
- Familiar with biobank or clinical trial environment
Requirements and Skills:
- Prior quality, compliance, or audit experience
- Must have knowledge and experience with GCP
- Strong communication skills
- Strong organizational skills
- Engages and motivates employees for improved results
- Clear understanding of business policy and practice throughout entire business
The company offers:
- Full time position in a fast growing business of biotechnology
- Excellent professional and career opportunities
- Open-minded executive management
- Friendly and supportive team
- Intellectually stimulating training from the best providers in biobanking field
- Attractive salary package and bonuses
- Fully paid vacation and sick leave