обновлено 10 дней назад
Senior Quality Validation Specialist (Life Sciences)
114 400 - 114 400$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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