Quality Assurance Specialist (Contract Position)

About Alveo At Alveo Technologies, we are reshaping diagnostics for a healthier and more sustainable future. We are the first company to make molecular detection and diagnostics universally accessible on the farm, in the field, clinic, or manufacturing plant – helping to prevent or significantly limit the destructive impact of viruses, fungi, bacteria, and other pathogens. By decentralizing molecular diagnostics across a broad range of industries, we enable rapid detection and decision making, timely action, and better outcomes at the Point of Need. Our portable, multiplex‑capable diagnostic platform, Alveo Sense, employs a patented method of direct electrical sensing of nucleic acid amplification to provide quick, affordable, and accurate results. Through early pathogen detection, we help manage global animal and human health, food security, and supply chain resiliency by providing actionable insights at light speed. Know Sooner, Act Faster with Alveo. We may use artificial intelligence tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us. Position Summary As a Quality Assurance Specialist, you will support the implementation and maintenance of the organization’s Quality Management System (QMS) to ensure products and processes meet established quality, regulatory, and performance requirements. This role is responsible for supporting Quality Assurance activities across document control, training compliance, equipment calibration tracking, batch record review, and lot release activities within a regulated laboratory and manufacturing environment. Key Responsibilities Document Review and Control – review controlled quality documents for formatting, completeness, accuracy, and compliance with company procedures prior to approval routing; assist with processing document changes, routing, version updates, obsolescence, and archival activities within the electronic Quality Management System (eQMS); maintain controlled records and ensure documents are properly filed, organized, and retrievable; review customer‑facing materials, labeling, and product documentation for compliance before release. Training and Support – assign required training within the eQMS based on document revisions and onboarding activities; monitor training completion status and follow up on overdue or incomplete assignments; maintain accurate and current training records; report training compliance issues to QA management as appropriate. Equipment Calibration and Maintenance – maintain calibration and preventive maintenance schedules for laboratory and manufacturing equipment; coordinate calibration and maintenance activities with internal personnel and external service providers; track completion and ensure records are uploaded; review calibration certificates for completeness; notify management of overdue items; assist with equipment labeling and status tracking. Batch Record Review / Lot Release – review batch records, test records, and supporting documentation for completeness, legibility, and adherence to procedures; verify signatures, dates, calculations, and documentation are present before QA approval; assist with production and laboratory records to support lot release; identify discrepancies and communicate findings; perform product disposition and lot release activities; maintain organized and traceable batch record and release documentation. Education and Experience Bachelor’s degree in Biological Sciences, Biomedical Engineering, Chemistry, Microbiology, or related scientific field, or equivalent combination of education and industry experience. Minimum of 3 years of experience working within a regulated laboratory, manufacturing, or quality environment. Experience in regulated industries (medical device, in‑vitro diagnostics, biotechnology, pharmaceutical, or related) with exposure to Quality Management Systems (QMS). Experience with electronic Quality Management Systems (eQMS) or electronic document management systems (eDMS) required. #J-18808-Ljbffr Alveo Technologies