Quality Assurance Associate

Sherlock Biosciences based out of Cambridge and Oxford, UK, is a wholly owned subsidiary of OraSure Technologies Inc. (OTI) and enables the democratization and decentralization of testing to personalize healthcare and make an impact on global health. Our products include molecular sampling kits for the genome and microbiome, and rapid diagnostics for infectious disease. Overview Here at OTI our innovative sampling tools and diagnostics unlock access to accurate, essential information that advances global health and well‑being. Summary The individual will be responsible for performing quality assurance functions related to ensuring compliance to applicable FDA, ISO, Canadian Medical Devices, and other country regulatory agencies’ requirements applied to currently approved products and products under development. Essential Duties and Responsibilities Review and approve documentation for incoming raw materials and manufactured products to ensure compliance with the Quality System requirements, including archiving of Device History Records, in accordance with established document retention policies. Assist in quality events (CAPAs, root‑cause analysis, etc.). Participate in the preparation and review of documents and procedures supporting compliance to Quality System requirements. Participate in evaluating Quality functions to ensure continuous improvement of the Quality System. Other tasks as assigned. Qualifications Strong planning, organizational and time‑management skills. Able to handle multiple projects simultaneously. Attention to detail, and good problem‑solving skills. Self‑motivated and able to work with minimum supervision. Well‑developed communication skills both written and oral. Physical Requirements Ability to work at least 40 hours in an office environment, flexible to work overtime as needed. Ability to follow written and oral directions, good communication skills. Ability to use office equipment. Ability to perform general mobility functions (e.g., sitting, bending, standing, filing, light lifting). Education and/or Experience Any scientific degree with 0‑2 years of experience in a regulated industry. Well‑developed PC skills, knowledge of Microsoft applications (Office, Excel, etc.) or equivalent required. £30,000 – £35,000 a year Benefits Private insurance, which includes supplemental health coverage and dental coverage. Life insurance benefits. Pension scheme. Paid time off. Maternity leave and parental leave coverage. Employee referral program – you may be eligible for a cash bonus if your referrals are hired. Employee assistance program. Employee service recognition. Job‑related training programs. Ability to participate in teams, committees, events and clubs. Depending on the role, you may be eligible to work in a hybrid environment or fully remotely. Free onsite parking. EEO Statement OTI encourages applications from all qualified candidates who represent the full diversity of the communities in which we operate. We apply a rigorous, consistent, and equitable standard to the assessment of all candidates, regardless of race, color, national origin, sex (including pregnancy), sexual orientation, gender identity, disability status, age, religion, veteran status, or any other protected characteristic. We are committed to creating a diverse and inclusive environment where all employees are welcomed and belong. If you require a disability‑related accommodation during the recruitment process, please contact Katheryn Viau at View email address on click.appcast.io. #J-18808-Ljbffr Medium