1 день назад
Associate II, Quality Control, Stability
63 200 - 100 900$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate II, Quality Control, Stability (GMP/biotech): Executing routine GMP stability programs for clinical and commercial programs with an accent on stability sample handling, controlled-temperature unit management, and compliant documentation. Focus on scheduling sample pulls, preparing submissions to external laboratories, maintaining data integrity, and supporting audits and regulatory inspections.
Location: Norwood, Massachusetts, United States; 100% onsite. Only U.S. persons are eligible due to U.S. export control requirements.
Salary: $63,200–$100,900 per year, with potential discretionary bonus, incentive compensation, or equity.
Company
develops mRNA technology and medicines through a biotechnology platform.
What you will do
- Execute routine GMP stability operations for clinical and commercial programs, including sample pulls, aliquoting, verification, set-downs, submissions, and shipment preparation.
- Create and maintain stability schedules to ensure sample pulls occur within defined timelines.
- Operate and monitor controlled-temperature units and cold rooms within validated ranges and loading patterns.
- Handle stability materials and samples according to procedures and protocols, and manage laboratory supplies and consumables.
- Respond to out-of-range temperature notifications and escalate issues to QC Stability management.
- Maintain compliant records, complete required training, and support audits and regulatory inspections.
Requirements
- Bachelor’s degree in a relevant scientific discipline.
- 2–3 years of experience in a GMP QC laboratory, preferably focused on stability in life sciences.
- Knowledge of cGMP requirements and general laboratory safety.
- Experience with pipetting, Microsoft Office, and electronic databases such as LIMS, SAP, eQMS, or CMMS.
- Strong written, oral communication, and organizational skills.
- Must work onsite in Norwood, Massachusetts and qualify as a U.S. person; visa sponsorship is not available.
Culture & Benefits
- In-person work model focused on direct collaboration, mentorship, and hands-on site operations.
- Healthcare and voluntary benefit programs.
- Fitness, mindfulness, and mental health resources.
- Family planning support, including fertility, adoption, and surrogacy benefits.
- Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
- Savings and investment programs, plus location-specific perks.
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