Quality Assurance Analyst at 54gene

Department: Compliance & Data Protection
Status: Full-time
Reports to: Director, Quality Assurance & Risk Management
Industry: Biotechnology

Position Summary

• We are looking for a Quality Assurance Analyst to join our team. You will be responsible for tracking and monitoring controls to ensure they are adequate and effective.
• To be successful in this position, you will be self-motivated, be able to work with minimal supervision with a good control of time management and industry/regulatory standards.

Duties and Responsibilities

• Support business units in the development of cross-functional processes and Standard Operating Procedures.
• Review functional and high-level process and SOP documentation for quality and adherence to defined methodology and standards.
• Provide input into the preparation of audit work plan and participate in the periodic evaluation/audits of operational processes.
• Provides insight into quality gaps discovered as part of the quality assurance process and ensures these gaps are communicated to appropriate management and business owners.  
• Analyses information gathered to develop recommendations for improvement and changes in current policies and procedures for continued compliance with business Policies/SOPs and applicable regulations.
• Maintain a tracker of all incidents for corrections and corrective actions.

Qualifications and Requirements

• Bachelor's Degree in Finance, Business, IT, or related field.
• 3 - 5 years of experience in as an analyst in a similar company or related fields
• Basic knowledge of Quality Assurance techniques, tools, and Quality Management Methodology.
• Solid knowledge of relevant regulatory and industry standards.
• Strong attention to detail.
• Proficiency in the use of Microsoft Word, Excel, Visio or other analysis and drawing programs.
• Effective time management skills and the ability to meet deadlines.
• Able to give and receive constructive criticism

Knowledge, Experience and Skills:

• Knowledge of Quality Assurance System Development and implementation such as ISO 9001:2015 QMS
• Quantitative and analytical skills with a demonstrated ability to understand new analytical concepts.
• Critical thinking skills with the ability to independently solve problems with data.
• Presentation skills, including public speaking and presentation creation using PowerPoint.
• Strong written and verbal communication skills to inform managers and other stakeholders of results