• Own, extend, and improve the test strategy and automation framework for our S3 implementation. • Define and articulate quality designs and test plans with appropriate technical depth, focusing on a shift-left approach. • Drive quality across the full development lifecycle — from design review participation through release validation. • Architect and troubleshoot test coverage for system-level components, with emphasis on file system behavior, storage system correctness, and S3 protocol compliance.

• Provide strategic and operational leadership in the planning and executing of GCP Quality activities to support companywide and clinical development/clinical trial Quality activities. • Successfully lead global and cross-functional quality projects • Maintains current knowledge of ever-changing clinical quality guidance and regulations. • Excellent communication and people skills to ensure cohesive and collaborative teamwork. • Demonstrated ability to implement and collaboratively drive company initiatives and policies. • Experience in clinical inspection readiness and acting as the point person for sponsor clinical inspections. Lead Quality hosting clinical site inspection by regulatory agencies highly preferred. • Direct experience to successfully manage and oversee CAPA plans (write, review, approve, close). • Successfully demonstrates ability to both conduct and manage sites, internal GCP and vendor audits as well as direct and guide audit follow-up actions. • Establish Quality and Cross-Functional SOPs, processes and associated documents. • Working closely with clinical pharmacovigilance team on supporting clinical trial safety. • Responsible for presenting & updating CGP quality metrics and reporting to Sr. Management. • Other duties as assigned.

Mixlab, the fast-growing veterinary compounding pharmacy, is hiring a Quality Associate. We are looking for a candidate who is obsessed with quality and is driven by an ability to #makeithappen for our customers and their furry (and scaly!) friends no matter what. You will be an integral part in helping us to ensure our nationwide quality operations run smoothly as we scale, and to make Mixlab a 100% dependable resource for our customers and veterinarians alike. This position will report to the Quality Manager. The role will assist with regulatory compliance and quality assurance across all sites. Responsibilities: - Assist with preparation for inspections by state boards, DEA, FDA, and accreditation boards (PCAB, NABP, etc) - Organizing and conducting internal quality system audits, playing an active role in external audits and regulatory inspections. - Assist in developing, reviewing, and maintaining Standard Operating Procedures (SOPs) for compounding, labeling, packaging, and dispensing. - Support adherence to USP <795>, <797> and <800>, VPP, and PCAB requirements where applicable to veterinary compounding. - Review and audit compounding logs, formulation worksheets, and beyond-use dating assignments for accuracy. - Develops, executes and analyzes QA reporting metrics, reports on quality issues and trends during monthly QMS meetings. - Qualification and validation procedures for equipment and processes. - Communicating with other team members to solve problems. - Following up with the appropriate channels when mistakes are found. - Performing other duties as requested, directed, or assigned. About You: - Bachelor’s degree in pharmaceutical sciences, chemistry, biology, or related field preferred; Certified Pharmacy Technician (CPhT) a plus - You have at least 1-3 years of experience working with a registered quality system in pharmaceutical production and/or manufacturing environment, FDA Good Manufacturing Practices and regulatory audits preferred. - You have very strong Microsoft Office Suite skills (Word, Excel, Outlook, etc) and ability to learn and operate other specific applications software. - You have strong oral and written communication skills, including making presentations, delivering training, writing/reviewing documentation, and working with auditors - You have the ability to read and understand complex regulations and requirements and develop pragmatic compliance solutions - You are a team player who can both take direction and show initiative as appropriate. - You are results-oriented, with an ability to manage multiple tasks simultaneously and expeditiously, have strong problem-solving skills and follow-through and a deep interest in working in the veterinary pharmaceutical space. - You’re not afraid of wearing multiple hats - you pitch in to help the team when necessary - You LOVE PETS and their people! $20 - $23 an hour

• Supervisar calidad de pruebas (internas y proveedores) • Definir estrategia de pruebas y automatización • Aprobación de calidad previo a despliegues (Go/No-Go) • Gestión de defectos end-to-end • Coordinación de UAT con usuarios • Generación de métricas (cobertura, defectos, MTTR) • Identificación de mejoras continuas en QA • Interacción directa con negocio / Product Owner