Quality Assurance Specialist

4 weeks ago

Cambridge, United Kingdom Novogene Full time

Novogene is a leading global provider of genomic services and solutions. Leveraging the latest next-generation sequencing (NGS), bioinformatics expertise, and the largest sequencing capacity in the world, Novogene provides unsurpassed data quality and fast turnaround time to all our customers.We are currently recruiting for a full time QA Specialist. This role is highly collaborative and requires drive and excellent time management skills. You will work closely with different business sectors and deliver activities to support business success and compliance. The suitable candidate must work on-site.Key Responsibilities:Manage the Quality, Environmental, Health & Safety function, maintaining ISO accreditations through a Continuous Improvement approach of the Quality Management System (ISO 17025, ISO 15189, ISO 14001, GCLP, HTA standards as appropriate).Assist with the Internal and external audit processes for the achievement of Certificates and Accreditations, along with any necessary follow-up actions.Responsible for the monitoring, maintenance and upkeeping of the QMS document systemResponsible for record keeping and archiving procedures following GCLP requirements.Train staff across Health and Safety, Environmental and QMS policies and procedures.Supports QA data collection for management reporting, business process and organisational planning.Responsible for the Risk Assessment, Safe Working Practice and COSHH assessment programIdentifying the implications of changes in legislation and/or guidance.Manage customer complaints, including containment actions, root cause analysis and countermeasures (CAPA system).Assist with supplier release and supplier performance evaluation, including record maintenance, as required.Act as an Internal Auditor and submit Internal Audit Reports to Management, ensuring compliance with internal and external standards and requirements.Responsible for Incidents and Non-conformances Investigations and reporting results to the UK management team.Any other ad hoc duties.About you:Master's degree (MSc) or higher in a relevant scientific discipline.Hands-on experience with molecular laboratory techniques, including DNA/RNA extraction, PCR, and NGS platforms.Experience in writing and reviewing Standard Operating Procedures (SOPs) and clinical diagnostic reports adhering to national quality standards. Expertise in quality management systems, particularly ISO14001 standardsExcellent verbal and written communication skills in English Ability to work both independently and as part of a multidisciplinary team.

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