Scientific Affairs and Quality Associate

Job Functions, Duties, Responsibilities and Position Qualifications:We're not just a workplace - we're a Great Place to Work certified employer!Proudly certified as a Great Place to Work, we are dedicated to creating a supportive and inclusive environment. At Sonic Healthcare USA, we emphasize teamwork and innovation. Check out our job openings and advance your career with a company that values its team members!Position SummarySonic Clinical Trials (SCT) is a leading provider of central and local laboratory services supporting pharmaceutical, biotechnology and medical device clinical trials. SCT is a wholly owned subsidiary of Sonic Healthcare, one of the world's largest specialist medical diagnostics companies.The position is based within a dynamic team environment at our Sonic Clinical Trials USA office and hybrid working is available upon completion of training.Key ResponsibilitiesDay to day management of key quality systems including:Non-Conformances and Complaints ManagementDocument, Risk, Audit, and Archive ManagementLaboratory Quality Control and Validation documentsChange ControlVendor ManagementTraining & Compliance Scientific AffairsSupport local and global quality projects, contributing to the development and maintenance of a strong quality-focused culture across the business.Liaise with referral laboratories on test scoping requirementsAssist with researching new assays/technologies for internalizationLiaise with Systems team for new analysis database configurationProvide input on SOPs, verification plans, and assay documentationCoordinate harmonization activities with regional and global laboratoriesRequirementsTertiary qualifications, as well as previous quality management systems experience, preferably within the pathology laboratory or other highly regulated laboratory environment.Experience working with CAP, CLIA, NYSDOH, ISO and strong working knowledge of GCP requiredExperience in a similar level, multi skilled position in a clinical laboratory environmentHighly developed analytical, problem solving and troubleshooting skills.Experience in computer system validation (CSV) in a QA role High level of computer literacy (e.g. MS Office suite or equivalent)Excellent communication skills, both written and oral (with the ability to influence stakeholders across the businessStrong interpersonal skills, high attention to detail, initiative, and ability to manage competing priorities and deadlinesAbility to effectively support local and global teams, reinforcing a consistent quality culture across regionsScheduled Weekly Hours:40Work Shift:Job Category:Laboratory OperationsCompany:Sonic Reference Laboratory, IncSonic Healthcare USA is an equal opportunity employer that celebrates diversity and is committed to an inclusive workplace for all employees. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, age, national origin, disability, genetics, veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Created: 2026-03-02