6 дней назад
Quality Assurance Specialist III - Viral Vector (Second Shift)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Assurance Specialist III - Viral Vector (Second Shift) (Viral Vector and Cell Therapy): Providing quality oversight for viral vector and cell therapy manufacturing operations with an accent on cGMP compliance, batch record review, and cleanroom support. Focus on leading complex investigations, deviations, CAPAs, and change controls while resolving quality issues and maintaining inspection readiness.
Location: Houston, Texas — onsite
Shift: Monday through Friday, 3:00 PM–11:30 PM
Company
manufactures medicines and advanced therapies across a globally connected network of more than 30 sites.
What you will do
- Provide quality oversight for viral vector and cell therapy manufacturing operations.
- Support manufacturing floor activities, critical operations, real-time quality decisions, and cleanroom work requiring gowning.
- Review and approve master batch records, executed batch records, GMP documents, and quality system records.
- Lead and support deviations, complex investigations, CAPAs, change controls, and continuous improvement initiatives.
- Collaborate with Manufacturing, Quality Control, Engineering, Facilities, Material Management, and other support functions.
- Maintain inspection readiness, regulatory compliance, accurate quality record tracking, and operational excellence.
Requirements
- Experience in a GMP-regulated biopharmaceutical, biologics, cell therapy, or viral vector manufacturing environment.
- Strong experience reviewing batch records, GMP documentation, and quality system records.
- Hands-on experience with QA floor support and cleanroom activities.
- Experience managing deviations, investigations, CAPAs, change controls, and quality systems processes.
- Working knowledge of cGMP, GDP, ISO standards, equipment and facility qualification practices, and regulatory requirements.
- An associate’s or bachelor’s degree in life sciences, engineering, or a related scientific discipline is preferred; relevant industry experience may substitute.
Nice to have
- Leadership, mentoring, or team coordination experience.
Culture & Benefits
- Performance-related bonus.
- Medical, dental, and vision insurance.
- 401(k) matching plan.
- Life insurance and short-term and long-term disability insurance.
- Employee assistance programs and paid time off.
- Values centered on collaboration, accountability, excellence, passion, and integrity.
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