QC Analyst

Responsibility Areas

• The key responsibility areas (KRAs) are major outputs for which the position is responsible and not a comprehensive statement of all position activities. 
Quality Control
Conduct systematic Quality Control reviews of client reports and data transfers
Deliver findings, observations and comments to scientific teams and conduct follow-up reviews
Lead the close out of QC reviews
Help ensure that high quality, accurate data are delivered to the client
Assist in identifying deviations, CAPA and lab investigations associated with laboratory data; and aid in addressing these where applicable
Record Keeping and Document Work
• Complete records as per required by company SOPs 
• May be required to review company documents (E.g. SOP revisions) as per applicable to the role
Accreditation
Adhere to the company’s Quality Management System which includes all Standard Operating Procedures (SOPs), noting we operate under NATA accreditation (ISO/IEC 17025, OECD Principles of GLP, and GCLP Principles) and are required to comply with ICH Good Clinical Practice for all clinical studies
Complete training and maintain awareness of applicable standards, regulations and guidelines as per applicable to the role
Safety
• Ensure the safe and efficient conduct of activities
• Ensure compliance to company OHS processes and statutory requirements 
Teamwork
• Maintain effective communication with colleagues, service providers and other partners.
• Work as a team both with QC and scientific departments to achieve client-ready reports and data transfers
Professional Development
• Attend meetings associated with Quality Control or the work of 360biolabs
• Participate in training courses and seminars as related to the role

Key Selection Criteria

Qualifications 
• Bachelor of Science (Hons) or equivalent qualification plus relevant experience (Essential)
Experience / Knowledge / Attributes
• Experience in a quality-controlled laboratory environment (preferably ISO/IEC 17025) (Essential)
• Knowledge of laboratory techniques & assays (Desirable)
• Excellent organisational and writing skills (Essential)
• Ability to work as part of a team (Essential)
• Good communication skills (Essential)
• High Attention to detail and a willingness to learn and ask questions (Essential)
• Proficient in use of Word Office, including Word, Excel, and PowerPoint (Essential)
• Experience with database software (Essential)
• Experience in the conduct of early phase clinical trials (Desirable)
• High motivation and enthusiasm for medical research, therapeutic and vaccine development (Desirable)