Quality Control Specialist (auditing)

Goal:

The Quality Control Specialist will audit  project documentation, operations processes, and analyze and report the results in a defined frequency.

Job Duties:

• 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

Minimum Qualifications:

• 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