QA Validation Specialist

hace 7 días

Santiago del Estero, Argentina Medable A tiempo completo

Company Description
Medable's mission is to get effective therapies to patients faster. We provide an end-to-end, cloud-based platform with a flexible suite of tools that allows patients, healthcare providers, clinical research organizations and pharmaceutical sponsors to work together as a team in clinical trials. Our solutions enable more efficient clinical research, more effective healthcare delivery, and more accurate precision and predictive medicine. Our target audiences are patients, providers, principal investigators, and innovators who work in healthcare and life sciences.

Our vision is to accelerate the path to human discovery and medical cures. We are passionate about driving innovation and empowering consumers. We are proactive, collaborative, self-motivated learners, committed, bold and tenacious. We are dedicated to making this world a healthier place.

**Job Description**:

- Review and approve UAT test scripts to ensure accuracy and completeness
- Review and approve completed UAT test scripts to ensure they are complete and contain objective evidence, as required
- Review and approve validation documentation to ensure it is accurate and complete
- Ensure documentation adheres to the processes and meets required standards
- Review and approve documentation and reports, associated with the validation of products
- Works closely with other departments and functions to promote processes that ensure consistency, continuous improvement, and compliance with quality and business requirements across activities
Provide QA assessment and review of GxP validated systems-related procedures, deviations, CAPAs, and change controls
- Provides guidance/mentoring to junior members of the QA team on less complex issues
- Participate in the continuous improvement and development of Quality Systems to ensure quality and adherence to GxP
- Identify, record, document, and track non-conformity issues
- Manage nonconformity issues and support the development and implementation of solutions
- Review and approve change requests
- Other duties as assigned

**Qualifications**:

- Experience as a Quality Assurance Engineer (preferred)
- Experience writing test scripts
- Experience testing mobile apps, web apps, and APIs
- Experience developing software (preferred)
- Critical thinking and problem-solving skills
- Great interpersonal and communication skills
- Attention to detail
- Flexibility and adaptability on managing/prioritizing multiple tasks
- 4+ years working in Software Development or a combination of education and experience
- Experience working in a GxP environment
- Experience performing validation work to meet 21 CFR Part 11, 21 CFR Part 820, ICH GCP, ISO 13485, and ISO 14971 requirements
**Minimum Level of Education/Preferred Skills**:

- Bachelor’s degree in Computer Science, Engineering, or related field
- Postman, Charles Proxy, Jira, Jmeter, H20, Oracle DB, SQL server, Kobiton, Confluence, Gitlab, Github

LI-REMOTE
LI-TH1

Additional Information

U.S. employees and contractors, and International workers with travel to the U.S. must have a willingness and ability to provide proof of completed COVID-19 vaccination prior to start date. All strongly held beliefs, religious, medical, and other legally recognized exemptions regarding vaccination status will be considered.

  • Senior QA Automation Engineer

    hace 6 días

    Mar del Plata, Buenos Aires, Argentina Launchpad Technologies Inc. A tiempo completo

    QA Automation Engineer (Full-Time, Remote – LATAM)Kick off your next career move with Launchpad We're looking for a driven QA Automation Engineer ready to take on the challenge of transforming manual testing processes into a robust, automated, and scalable quality ecosystem. If you're passionate about automation frameworks, CI/CD integration, and building...

  • Contract Administration Specialist | Córdoba | Remote

    hace 2 semanas

    Cruz del Eje, Argentina Opsarmy A tiempo completo

    Job Description : Contract Administration Specialist Position Type : Full-Time (45 hours / week) Schedule : EST hours with 1 weekend day (TueSat or SunThu) Location : Remote Apply here : About the Role OpsArmy is seeking a Contract Administration Specialist to manage the review, validation, and processing of financial and contractual documents for our...

  • QA Automation

    hace 4 días

    Mar del Plata, Buenos Aires, Argentina Somnio Software A tiempo completo

    Job description Make an impact in your CareerAs a QA Automation Engineer at Somnio Software, you will be the architect of robust and efficient testing frameworks, ensuring the quality and reliability of our applications. You will work hand in hand with a talented team, leveraging the latest automation tools and methodologies to bring innovative projects to...

  • QA & Logistics Specialist: Asset Quality & Shipping

    hace 3 semanas

    Mar Del Plata, Argentina Personify Health A tiempo completo

    Una empresa de logística y calidad en Mar del Plata busca un Quality Assurance & Logistics Specialist. El candidato ideal supervisará procesos de ensamble y mantenimiento, controlará la calidad y gestionará el stock de activos. Se requiere un mínimo de 2 años de experiencia en roles similares y proactividad. Este puesto es a tiempo completo, con un...

  • Protein Purification Analyst

    hace 3 días

    Mar del Plata, Buenos Aires, Argentina Planet Pharma A tiempo completo

    Job Opportunity: Senior Purification Analyst We are seeking an experienced Senior Purification Analyst to join a leading biopharmaceutical production team. This role is based at a modern manufacturing site and offers the chance to contribute to innovative protein purification processes within a GMP-regulated environment. Key ResponsibilitiesCarry out...

  • Software Support Engineer

    hace 6 días

    Mar del Plata, Buenos Aires, Argentina Simpalm | Digital Innovation A tiempo completo

    Simpalm is hiring an experienced Software Support Specialist to provide high-quality application and user support to internal employees and system users.This role involves resolving inquiries, recommending solutions, educating users on software features, and helping them understand the full value of the tools they use daily.Key ResponsibilitiesRespond...

  • Programmatic Specialist

    hace 1 semana

    Mar del Plata, Buenos Aires, Argentina Brainlabs A tiempo completo

    We currently have several openings for amazing Programmatic Specialist to join our Buenos Aires office working across amazing clients such as Hilton, Walmart, Unicef and moreSo you're interested in becoming a Specialist, Programmatic? Let's dive into what that means:As a Specialist your focus is delivering high-quality, best-in-class work for clients within...

  • E-commerce Specialist

    hace 4 días

    Mar del Plata, Buenos Aires, Argentina The Global Talent Co. A tiempo completo

    Full-time | Remote | LATAMAbout Us:At The Global Talent Co., we provide opportunities to work with leading innovative technology companies worldwide, offering stable employment, competitive compensation, career growth, and access to a community of 25k+ like-minded marketing professionals.Our mission is to bridge the gap between leading global tech companies...

  • Jr. Payment Specialist Engineer

    hace 4 semanas

    Mar Del Plata, Argentina Belong A tiempo completo

    About Belong We believe everyone can own a rental Home. Our mission is to provide authentic belonging experiences, empowering residents to become homeowners and homeowners to be financially free. It's where Engineering and hospitality meet consumer real estate—and it's redefining an entire industry. We're backed by Andreessen Horowitz (a16z), GGV Capital,...

  • Senior Purification Analyst

    hace 6 días

    Mar del Plata, Buenos Aires, Argentina Mantell Associates A tiempo completo

    Mantell Associates is partnered with a leading Biopharmaceutical company, who is seeking an experienced Senior Purification Analyst to join its production team at the Buenos Aires facility.This position offers an exciting opportunity to contribute to large-scale protein purification processes in a GMP-regulated environment, driving operational excellence and...