11 дней назад
QC Specialist III - Stability (Pharmaceutical)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
QC Specialist III - Stability (Pharmaceutical): Managing GMP stability studies from setup through final reporting with an accent on protocol development, controlled documentation, sample coordination, and customer communication. Focus on coordinating cross-functional testing, supporting investigations and change controls, and developing stability best practices in a regulated laboratory environment.
Location: On-site in Portsmouth, New Hampshire, United States; Monday-Friday, 7:00 AM-3:30 PM
Company
operates globally connected sites that manufacture medicines and support the development of life-changing therapies.
What you will do
- Manage stability studies from setup through completion, ensuring quality, GMP compliance, and timely delivery.
- Act as the primary stability contact for customers and provide updates throughout the study lifecycle.
- Develop, review, and maintain stability protocols, reports, and GMP documentation.
- Coordinate testing activities, sample management, study timelines, and internal and external partners.
- Collaborate with Quality Control, Quality Assurance, Program Management, and Operations teams.
- Support investigations, change controls, continuous improvement, mentoring, and stability best practices.
Requirements
- Experience managing stability studies in a GMP-regulated pharmaceutical, biotechnology, or related industry.
- Strong knowledge of stability protocols, reports, controlled documentation, and quality systems.
- Ability to build customer relationships and communicate effectively with cross-functional teams.
- Experience coordinating multiple priorities in a fast-paced environment, with demonstrated problem-solving and independent working skills.
- Associate's or Bachelor's degree in Life Sciences or a related field, or an equivalent combination of education and experience.
- Experience in Quality Control, Stability, or another regulated laboratory environment is preferred.
Culture & Benefits
- Agile career environment with opportunities for professional development and growth.
- Inclusive, ethical, and collaborative workplace with broad cross-functional exposure.
- Medical, dental, and vision insurance.
- Compensation programs that recognize high performance.
- Opportunity to contribute to therapies that improve patients' lives.
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