Sr. Quality Assurance
2 weeks ago
Sr. Quality Assurance / Document Control Specialist ImpriMed is transforming both veterinary and human oncology with its cutting‑edge AI‑driven precision medicine approach. ImpriMed’s innovative AI models leverage live cancer cell analytics to enable oncologists to make precise, data‑driven treatment decisions tailored to individual patients. With proven success in over 10,000 cases in dogs and cats, the company is now expanding into human cancer treatment. Additionally, the live‑cell‑based drug efficacy assessment platform, xCellSense, offers pharmaceutical companies an invaluable tool to pretest drug compounds on their target patients’ live cells, enhancing clinical trial success rates and streamlining market entry. WHAT YOU WILL DO The Sr. Quality Assurance / Document Control Specialist is responsible for maintaining and improving ImpriMed’s Quality Management System (QMS) and operations to ensure compliance with CLIA, HIPAA, FDA QSR, and ISO 17025 requirements. This role will support Quality Assurance for ImpriMed’s diagnostic laboratory services and Software as a Medical Device (SaMD) products, document control processes, support internal and external audits, and assist in implementing quality policies across laboratory operations. PRIMARY RESPONSIBILITIES Manage and maintain the company’s document control system, ensuring all controlled documents are current, approved, and properly distributed Support QMS compliance with CLIA, HIPAA, FDA QSR, and ISO 17025 regulations Coordinate document change control activities (SOPs, forms, work instructions, quality manuals) Review and maintain training records to ensure personnel are trained to current procedures Manage supplier qualification, equipment calibration, and validation documentation Implement and maintain quality control processes for laboratory assays and products Support CAPA, nonconformance, deviation, and complaint handling processes Prepare and participate in internal, customer, and regulatory audits and inspections Monitor quality metrics and prepare reports for management review Collaborate cross‑functionally with Bioscience, Datascience, Software Engineering, and Operations teams to ensure quality system alignment and continuous improvement QUALIFICATIONS & SKILLS Required: Bachelor’s degree in a scientific, engineering, or related discipline (or equivalent experience) 3+ years of experience in Quality Assurance or Document Control in a regulated environment (diagnostics, medical device, or pharmaceutical industry) Working knowledge of CLIA, HIPAA, FDA QSR, or ISO 17025 requirements Strong organizational and communication skills with attention to detail Preferred: Experience supporting audits and regulatory inspections Experience with design control documentation and risk management Experience in a startup or small company environment WE OFFER Competitive compensation based on experience (Base salary range $80,000 to $90,000) Flexible vacation policy 401(k) APPLICATION INSTRUCTIONS To learn more about this position or to apply, please email atjobs@imprimedicine.com. ImpriMed, Inc. is an Equal Opportunity Employer. ImpriMed, Inc. does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, non‑disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law. All employment is decided based on qualifications, merit, and business need. #J-18808-Ljbffr
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