• Executar testes manuais em aplicações web, validando funcionalidades e fluxos do sistema • Identificar, reproduzir e documentar bugs de forma clara e estruturada • Validar integrações com APIs e comportamento de requisições no navegador • Criar e executar casos de teste com base em cenários de uso reais • Apoiar na documentação de funcionalidades, incluindo changelogs e instruções de uso • Garantir a qualidade das entregas antes de publicações em produção • Participar de rituais ágeis e colaborar com times de Produto e Desenvolvimento • Sugerir melhorias com base na experiência de uso e testes realizados

• Serve as the quality lead and subject matter expert for critical global suppliers of GMP raw materials • Own the end-to-end quality oversight of assigned suppliers—from onboarding through ongoing performance monitoring to disengagement • Act as the primary quality contact for internal stakeholders, supporting issue resolution, supplier strategy, and cross-functional initiatives • Perform proactive quality management of suppliers, ensuring compliance with global regulatory standards • Review and approve quality documentation • Participate in and/or lead supplier audits and collaborate with internal and external partners • Prepare Amgen sites and suppliers for audits and inspections • Identify and mitigate risks at the supplier and/or escalate to management • Drive audit commitments to completion. • Act as a key quality partner to External Supply, Manufacturing, Supply Chain, Material Sciences, Engineering Technical Authority (ETA), Process Development and other internal functions. • Take the lead and/or participate in cross-functional initiatives and continuous improvement projects.

• Lead and manage IT compliance and quality projects • Deliver client engagements focused on IT compliance, including but not limited to FDA, EU EMA, and other global health authority regulations, privacy regulations (GDPR, CCPA, etc.) or CAP/CLIA regulations. • Oversee the end-to-end lifecycle of IT compliance projects, from initial assessment and requirements gathering to implementation, validation, and post-implementation support. • This includes Computer Systems Validation (CSV) and, importantly, applying modern approaches to Computer Software Assurance (CSA) per FDA guidance and GAMP 5. • Lead technical discussions, document key compliance decisions, and track action items. • Ensure that projects meet client expectations, are completed on time, and align with relevant regulations and industry best practices (including 21 CFR Part 11, EU Annex 11), emphasizing true risk-based approaches to validation. • Maintain personal billable utilization at the rate of 1700 hours per year. • Develop compliance-focused client deliverables. • Create high-quality, client-ready deliverables that communicate complex IT compliance requirements and solutions in a clear and compelling way. • Utilize advanced skills in Excel and PowerPoint to develop detailed compliance roadmaps, IT strategy documents, system validation plans, and risk assessments. • Design technology presentations and reports that articulate business value and demonstrate how the proposed solutions will address client compliance challenges, improve data integrity, and mitigate risks. • Develop Policies, Procedures, Forms, and Templates to drive regulatory compliance in the IT domain. • Develop formal systems validation documentation (eg Validation Plans, Requirements/Specifications, Risk Assessments, Test Plans, Trace Matrices etc.) • Assist clients to improve and modernize their approaches to IT compliance • Lead data collection, IT analysis, and assessments related to IT compliance and Data Integrity. • Take the lead in gathering data and conducting analyses to understand and remediate client compliance challenges. • Conduct system audits, evaluate IT systems for compliance gaps, assess data integrity risks, and identify opportunities for compliance improvement and automation. • Assist customers to evaluate and/or implement technologies that automate compliance tasks, including ALM/VLM solutions or automated testing software, as well as ITSM solutions to manage change control. • Design technology solutions and architectures that meet regulatory requirements and incorporate best practices for data governance and security. • Develop sophisticated models for assessing IT compliance, cost structures, and risk mitigation. • Experience with qualification and/or validation of on-premises and cloud-based infrastructure and applications, including SaaS. • Manage and communicate complex IT compliance concepts to both technical and non-technical audiences; this will be critical to driving project success and ensuring that client expectations are consistently met or exceeded. • Actively contribute to business development activities by identifying IT compliance opportunities within existing client relationships and helping to acquire new clients. • Conduct compliance assessments, prepare proposals for IT compliance solutions, and contribute to the firm’s position as a leader in IT compliance within the life sciences industry. • Foster relationships with senior IT and Quality executives and influence decision-makers; this will be crucial to driving revenue growth and expanding the firm’s IT compliance consulting offerings.

Role Description We are seeking experienced freelance English<>Vietnamese linguists to support upcoming healthcare and medical projects across multiple shifts. Coverage across time zones is required as outlined below: - English ↔ Vietnamese - Morning shift: 6:00 AM – 2:00 PM (EST) - Afternoon shift: 2:00 PM – 10:00 PM (EST) - Night shift: 10:00 PM – 6:00 AM (EST) Candidates should be able to provide reliable availability (4 to 8 hrs) within the specified time frames. - Translation, Machine Translation Post-Editing (MTPE), and QA (memoQ) - Ensure accuracy, consistency, and adherence to client guidelines - Meet deadlines and maintain communication Qualifications - Experience in healthcare/medical content - Native-level Vietnamese + strong English - memoQ experience preferred Requirements - Payment in USD To Apply Please send your resume and your rates for the following to araceli.charro@biglanguage.com with the subject line: EN–VIETNAMESE, and confirm your shift availability. Benefits This is a full time position.