The Quality Assurance Specialist III provides independent Quality support for GLP and GCLP studies by performing document review, protocol and experiment record review, data review, and quality event oversight activities.
Requirements
- Bachelor’s Degree or Master Degree in Life Sciences, Pharmacy, Biology, Chemistry
- 4 years of related experience in a life science GxP environment with CRO experience preferred
- High attention to detail
- Strong written and verbal communication
- Ability to meet deadlines and perform administrative functions
- Data review expertise across computerized systems including LIMS
- Understanding of Audit trails, metadata, and system validation
- Knowledge of Computer System Validation (CSV) and Computer System Assurance (CSA)
- Data governance frameworks
- Microsoft Office suite proficiency including Office Word, Excel, PowerPoint
- Ability to organize tasks, work independently and adapt to changing priorities
Benefits
- Paid Time Off
- 401k Matching
- Health Insurance
- Dental Insurance
- Vision Insurance