3 дня назад
Stability Coordinator (Biotechnology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Stability Coordinator (Biotechnology): Administering stability studies for medicines by coordinating materials, authoring protocols, managing analytical data, and maintaining stability chamber inventories with an accent on GMP compliance and cross-functional quality control. Focus on preparing and tracking samples, reviewing study data, supporting regulatory submissions, and maintaining precise pull schedules across multiple ongoing studies.
Location: Rensselaer, New York, United States; onsite, Monday through Friday, 1st shift
Company
is a biotechnology company that develops and commercializes medicines for serious diseases.
What you will do
- Coordinate with departments to identify materials for stability studies.
- Author stability protocols and obtain required approvals before studies begin.
- Review analytical data and compile it in a central database.
- Provide stability data for regulatory submissions and internal requests.
- Manage stability chamber inventory and monitor chamber performance.
- Prepare, label, distribute, retrieve, and submit samples according to study protocols and pull schedules.
Requirements
- Bachelor's degree in life sciences or a related field.
- Strong attention to detail and comfort working with data in a regulated environment.
- Ability to work independently and collaboratively across functions.
- Clear written and verbal communication skills for authoring protocols and reporting data.
- Compliance with applicable regulatory requirements, including GMP standards.
Nice to have
- Experience with stability programs, quality control, or analytical testing.
- Familiarity with GMP or other regulated laboratory environments.
- Experience with databases used to compile and track scientific data.
- Exposure to regulatory submissions or interaction with regulatory agencies.
Culture & Benefits
- Student Loan Paydown program and tuition reimbursement.
- Family care benefits.
- Inclusion, culture, and well-being programs supporting physical and mental health.
- Collaborative work across Quality Assurance, Regulatory Affairs, Manufacturing, and external testing partners.
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