Biotechnology Compliance Specialist
7 days ago
**Job Overview:**
System One Holdings, LLC is a premier pharmaceutical and biotechnology company committed to scientific breakthroughs and revolutionary medicines.
**Estimated Salary Range:** $65,000 - $85,000 per year.
**Key Responsibilities:**
- Support Quality Operations by performing Quality Control activities associated with clinical and/or commercial product, raw materials, validation, and stability.
- Maintain compliant Quality Control and Stability laboratories by performing GMP tasks.
- Provide sample management support for QC, including pick up from manufacturing, maintaining chain of custody in LIMS, aliquoting/delivering samples to appropriate lab, etc.
**Requirements:**
- Knowledge of current Good Manufacturing Practices (cGMP), Laboratory Information Management System (LIMS), Microsoft Office applications specifically Word and Excel, analytical techniques and instrumentation, Lean Six Sigma concepts, and Lean Labs.
- FDA / GMP Compliance, GDP Documentation, Labware LIMS, Sample management and handling, Bioworks Certification with 2+ years of experience or Bachelor's degree.
**Benefits:**
- Health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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