6 дней назад
Quality Assurance Specialist II - Viral Vector
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Assurance Specialist II - Viral Vector (GMP/cell therapy): Providing quality oversight for viral vector and cell therapy manufacturing operations with an accent on cGMP compliance, batch record review, and cleanroom quality support. Focus on investigating deviations, CAPAs, and change controls, resolving manufacturing quality issues, and maintaining inspection readiness.
Location: Houston, Texas — onsite; Monday–Friday, 7:30 AM–4:00 PM
Company
manufactures medicines and life-science products through globally connected operations across more than 30 sites on five continents.
What you will do
- Provide quality oversight for viral vector and cell therapy manufacturing operations.
- Support manufacturing floor activities, including line clearances, critical operations, and quality-related decisions.
- Review and approve Master Batch Records, executed batch records, and GMP documentation for product disposition.
- Conduct QA walkthroughs and collaborate with Manufacturing, Quality Control, Engineering, and other support functions to resolve quality issues.
- Support investigations, deviations, CAPAs, change controls, and other quality system processes.
- Perform Grade B cleanroom activities requiring Level 3 gowning and maintain inspection readiness and quality records.
Requirements
- Associate degree in Life Sciences, Engineering, or a related scientific discipline preferred; relevant industry experience may substitute.
- Experience in a GMP-regulated biopharmaceutical, biologics, cell therapy, or viral vector manufacturing environment.
- Hands-on cleanroom and gowning experience in classified manufacturing environments.
- Experience reviewing GMP documentation and batch records with strong attention to detail.
- Knowledge of deviations, CAPAs, change controls, and quality systems processes.
- Strong communication, collaboration, problem-solving, and decision-making skills in a fast-paced manufacturing environment.
Nice to have
- Cell therapy or viral vector manufacturing experience.
Culture & Benefits
- Performance-related bonus.
- Medical, dental, and vision insurance.
- 401(k) matching plan.
- Life insurance and short- and long-term disability insurance.
- Employee assistance programs and paid time off.
- Work focused on quality, compliance, operational excellence, and patient safety.
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