Stability Technician I
QC Stability Technician
Overview We are seeking a detail-oriented QC Stability Technician to support stability studies that ensure the quality and efficacy of drug products throughout their shelf life. This role involves managing stability samples, performing sample pulls and aliquoting, and maintaining accurate documentation in compliance with industry standards. Key Responsibilities- Initiate and manage stability studies, including sample pulls and aliquoting.
- Maintain and update stability databases to track all studies accurately.
- Ensure proper labeling, storage, and disposal of stability samples.
- Prepare and label samples; manage inventory of stability samples.
- Analyze stability data to identify trends and degradation patterns.
- Write stability protocols and generate data reports.
- Adhere to Good Manufacturing Practices (GMP) and regulatory guidelines (FDA, ICH).
- GMP compliance
- Stability testing and sample handling
- Aliquoting and data analysis
- Familiarity with FDA and ICH guidelines
- Bachelor’s degree in a relevant science field or equivalent experience in a GMP environment.
- Knowledge of regulatory requirements for stability studies.
- Proficiency with software tools for data entry, analysis, and reporting.
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
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