4 дня назад
Validation QA Specialist
110 000 - 120 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Validation QA Specialist (GMP/Validation Documentation): Reviewing and approving validation records for regulated pharmaceutical, biotechnology, or medical device environments with an accent on GMP compliance, traceability, and document control. Focus on resolving documentation deficiencies, managing deviations and CAPAs, and maintaining inspection-ready quality systems.
Location: Pomona, United States; must be authorized to work in the U.S.
Salary: $110,000–$120,000 annually
Company
provides consulting and professional services for pharmaceutical, biotechnology, and medical device clients through a globally distributed organization.
What you will do
- Review and approve validation documentation for accuracy, completeness, traceability, and technical adequacy.
- Verify compliance with GMP requirements, internal procedures, regulatory expectations, and document control standards.
- Review quality system records related to validation, including deviations, investigations, CAPAs, and change controls.
- Collaborate with Validation, Engineering, Manufacturing, and Quality teams to resolve documentation deficiencies.
- Support audit and inspection readiness and participate in internal audits and regulatory inspections.
- Contribute to continuous improvement initiatives for validation documentation and quality systems.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, Quality Assurance, or a related scientific discipline.
- At least 5 years of experience in Quality Assurance, Validation, or validation document review in a regulated GMP environment.
- Experience reviewing and approving validation documentation, including IQ/OQ/PQ protocols and reports.
- Knowledge of validation lifecycle documentation, risk assessments, change controls, deviations, CAPA, and document management systems.
- Working knowledge of FDA, EU GMP, and ICH regulatory requirements.
- Strong attention to detail, communication skills, independent working ability, and experience managing multiple priorities.
Culture & Benefits
- Medical, dental, and vision coverage, with PSC paying 100% of qualifying employee medical premiums and 50% for qualifying dependents.
- Employee assistance programs, life insurance, and short- and long-term disability coverage.
- 401(k) plan with matching contributions.
- Paid time off, sick time, and paid holidays.
- Education assistance, pet insurance, fitness discounts, and financial perks.
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