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Senior Quality Validation Specialist (Life Sciences)

114 400 - 114 400$
Формат работы
onsite
Тип работы
project
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 Validation Specialist (Life Sciences): Providing technical leadership and quality oversight for validation activities within a regulated manufacturing facility with an accent on IQ/OQ/PQ protocols, change requests, and non-conformity investigations. Focus on ensuring a constant state of validation and compliance through rigorous technical reviews and root cause analysis during regulatory audits.

Location: Rensselaer, United States; onsite work in a regulated manufacturing facility.

Salary: $114,400

Company

hirify.global provides staffing and employment services for technical and life sciences roles.

What you will do

  • Provide quality oversight and approval for validation activities related to system changes and site-wide projects.
  • Lead the preparation, execution, and data analysis of Installation, Operational, and Performance Qualification protocols.
  • Review validation documentation, protocol data, change requests, and non-conformity investigations.
  • Apply root cause analysis to validation failures and support robust corrective actions.
  • Present validation concepts and documentation during internal audits and external regulatory inspections.
  • Manage assigned Annual Product Reviews and collaborate with engineering, R&D, and management.

Requirements

  • PhD with 4+ years, MA/MS with 6+ years, or BA/BS with 8+ years of relevant experience in chemistry, engineering, or a related field.
  • Extensive validation or quality experience in drug development or life sciences.
  • Expertise authoring and reviewing IQ/OQ/PQ protocols and reports.
  • Strong knowledge of root cause analysis and failure investigation methodologies.
  • Ability to communicate complex validation requirements across organizational levels.
  • Commitment to safety practices in a laboratory or manufacturing environment.

Culture & Benefits

  • Work in a highly regulated manufacturing environment focused on compliance and continuous process improvement.
  • Temporary assignments lasting 13 weeks or longer may include medical, dental, vision, and 401(k) benefits.
  • Statutory sick pay is provided where required.
  • Reasonable accommodations are available during the employment process.

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