Quality Assurance Scientist

About the OpportunityWe’re working with an innovative, mission-driven organization operating in a highly regulated and fast-evolving industry. This team is focused on advancing meaningful work that has a real impact, while continuing to scale its operations and infrastructure. It’s a great opportunity to step into a role where you can bring structure, improve processes, and support a growing business.Position OverviewThe Quality Assurance Scientist will be responsible for ensuring compliance with quality systems, regulatory standards, and internal procedures across laboratory and operational processes. This role plays a critical part in maintaining product integrity, supporting validation activities, and driving continuous improvement initiatives.The position partners closely with Quality, Laboratory, Manufacturing, and Regulatory teams to ensure all processes meet applicable standards and are inspection-ready at all times.Key ResponsibilitiesSupport and maintain the Quality Management System (QMS), ensuring alignment with regulatory requirements (e.g., GMP, GLP, GxP) Review and approve laboratory documentation, including batch records, test results, and standard operating procedures (SOPs) Conduct internal audits and participate in external audits and regulatory inspections Investigate deviations, non-conformances, and out-of-specification (OOS) results, ensuring timely root cause analysis and corrective/preventive actions (CAPA) Partner with cross-functional teams to support process validation, method validation, and technology transfers Ensure proper documentation practices and data integrity across all quality and laboratory systems Monitor quality metrics and trends to identify risks and drive continuous improvement initiatives Support change control processes, ensuring proper assessment and documentation of changes Assist in training staff on quality standards, compliance requirements, and best practicesRequired QualificationsBachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field); advanced degree preferred 3–5 years of experience in Quality Assurance within a regulated industry (e.g., pharmaceuticals, biotechnology, life sciences) Strong knowledge of GMP, GLP, and/or GxP regulations and quality systems Experience with deviation investigations, CAPA management, and audit support Familiarity with laboratory operations, analytical testing, and validation processes Strong understanding of data integrity principles and documentation standards Excellent analytical, problem-solving, and attention-to-detail skills Ability to manage multiple priorities in a fast-paced, regulated environment Strong written and verbal communication skills, with the ability to collaborate cross-functionally