quality controlrisk managementcompliancesdlcgxp21 cfr part 11software validationich e6
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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Роль четко связана с соблюдением требований и валидацией ПО для клинических исследований, но высокая ответственность и нехватка деталей о повседневной работе оставляют практические вопросы.
Quality Control Analyst (Compliance & Quality) (Clinical Trial Technology): Ensuring software development activities, validation deliverables, product releases, and quality processes comply with Suvoda procedures and clinical-trial requirements, with an accent on GxP regulations, SDLC validation, and risk-based quality control. Focus on identifying pre-release issues, reviewing corrective actions and QMS documents, validating IT systems and vendors, and improving compliance processes.
Location: Conshohocken, Pennsylvania, United States
Company
hirify.global is a global clinical trial technology company developing digital experiences for clinical trial sponsor and site professionals, including solutions supporting oncology, central nervous system, and rare disease studies.
What you will do
Ensure software development activities and deliverables comply with hirify.global procedures.
Identify, document, and report issues before product or service release, and release products and systems through development phases.
Review and approve SDLC, validation, and QMS deliverables, including procedure deviations.
Perform in-process verifications and support corrections and corrective actions with delivery teams, system owners, and Compliance and Quality stakeholders.
Plan and execute internal IT validation, external-party software validation, migration, and third-party vendor qualification projects.
Contribute to process improvements and act as a subject matter expert where qualified.
Requirements
1–3+ years of experience in a similar role.
Bachelor’s degree.
Knowledge of GxP regulations, including 21 CFR Part 312, Part 11, Annex 11, and ICH E6, is preferred.
High-achieving personality, strong work ethic, proactive attitude, and sense of ownership.
Desire to learn and grow.
Time management, organization, attention to detail, and risk-based judgment skills.
Culture & Benefits
Work involves complex, high-stakes, and dynamic clinical trials supporting time-sensitive patient interactions.
Collaboration with delivery teams, system owners, vendors, and Compliance and Quality stakeholders.
The role requires working with clinical trial regulations, hirify.global products and processes, and trial-specific requirements.
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