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9 часов назад

Quality Control Analyst (Compliance & Quality)

Формат работы
onsite
Тип работы
fulltime
Грейд
junior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
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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