Genuity Science is a contract genomics and data-sourcing, analytics and insights organization headquartered in Boston, Massachusetts, USA with offices in Dublin, Ireland and Reykjavik, Iceland. Genuity partners with global biopharma companies to offer deep end-to-end discovery services aimed at catalyzing precision health and improving the quality of life for patients around the world. Services include population-scale, disease-specific data sourcing, high-quality sequencing, robust statistical analysis and software tools for analyzing large datasets and artificial intelligence (AI). The company operates an advanced CAP genomics laboratory in Dublin, Ireland and is deeply committed to data stewardship and data governance across its global offices. For more information, see [...] Quality function plays a crucial role in the Company by ensuring that Company practices meet the required standards of quality. The candidate will support the Quality Manager in developing and maintaining the company Quality Management System (QMS) in line with ISO 9001:2015 standards to ensure quality is built into our Operational Pipeline. The ideal candidate is an exceptionally organized, methodical professional with meticulous attention to detail.
Duties and Responsibilities
Contribute to the development, definition, and improvement of company processes in the form of policies, SOPs and records
Develop, optimise and maintain electronic QMS applications
Maintain the document control system and assist and guide staff in the development of controlled documents
Work within a team to perform quality reviews of documents in a timely manner
Maintain deviation/nonconformance processing through records and tracking systems, including root cause and corrective actions to achieve effective outcomes.
Maintain change management system/database to track record status and help drive the records to closure
Maintain training management system/database to track training completion rates
Assist in the internal auditing programme.
Collect data to help monitor quality assurance performance using trending, quality metrics and internal audits
Identify improvement opportunities and training needs to ensure company-wide compliance
Provide training and support to staff as needed to ensure consistent standardised approach to QMS processes
Qualifications and Required Experience
2-4 years experience in a quality systems related role
Professional certification, such as Lean Six Sigma, Quality Auditor advantageous
Excellent computer competence, including excel and word form/template developer functions, and database management
Knowledge of quality assurance terminology, methods, and tools
Excellent analytical, problem-solving, and decision-making skills
Strong attention to detail and a results-driven approach
Proficiency in the use of QM systems and tools
Strong interpersonal skills
Ability to work in cross-functional team environments