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3 дня назад

Senior Quality Assurance (QA) Auditor (Genomics Laboratory)

75 400 - 188 600$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
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
Senior Quality Assurance (QA) Auditor (Genomics Laboratory) (GxP/pharmaceutical research): Planning and conducting independent audits in laboratory and research environments with an accent on regulatory compliance, quality systems, and inspection readiness. Focus on evaluating compliance risks, supporting RCA and CAPA investigations, maintaining eQMS activities, and driving quality improvement initiatives.

Location: Durham, North Carolina, United States

Salary: $75,400–$188,600 annualized base pay

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

  • Plan, schedule, conduct, and close independent quality audits across laboratory and research environments.
  • Review findings, prepare audit reports, and communicate results to operational teams, management, and clients.
  • Provide guidance on regulatory requirements, quality standards, compliance status, and procedures.
  • Support investigations, root cause analysis, CAPA activities, and effectiveness checks through closure.
  • Host and support customer audits, mock inspections, and regulatory inspections.
  • Maintain eQMS activities and contribute to quality improvement, process optimization, compliance programs, onboarding, and training.

Requirements

  • At least 5 years of experience in a pharmaceutical, technical, or related area, including 3 years in Quality Assurance.
  • Experience with GxP and pharmaceutical research and development processes.
  • Knowledge of quality assurance procedures, audits, inspections, quality systems, and regulatory environments.
  • Proficiency with word-processing, spreadsheet, database, and electronic Quality Management System applications.
  • Strong problem-solving, risk analysis, negotiation, decision-making, communication, organization, and collaboration skills.
  • A bachelor's degree is preferred; equivalent education, training, and experience may be accepted.

Culture & Benefits

  • Inclusive collaboration focused on advancing healthcare research and development.
  • Benefits and resources supporting employees' physical, mental, emotional, financial, and social well-being.
  • Health and welfare benefits may be provided in addition to base pay.
  • Potential incentive plans, bonuses, and other compensation may be available depending on the position.

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