Category: Scientific & Clinical
Title: Quality Specialist - II
Location: Durham, NC
Start date: ASAP
- Leads the development, validation, and routine testing of product through the performance of microbiological, chemical and analytical sampling and assays
- Interacts with Production, Quality Assurance, Validation and Facilities, as necessary to support manufacturing.
- Support of biological assay of products including chemistry and microbiology assays.
- Testing of products, continuing process improvements, troubleshooting, writing SOPs, investigational testing support, change control support, quality risk assessment support.
- Evaluate and implement new analytical technologies that expand site capabilities.
- Apply project management concepts and techniques as they relate to analytical testing, regulatory requirements for assay development/validation, project timelines
- Work in a highly functioning diverse team environment
- Understand and apply cGMP/GLP, Compendial, and other applicable regulatory requirements toward analytical testing
- Capability to function effectively within an automated/electronic laboratory environment
- Bachelor's Degree in Science, Engineering, or related areas of study.
- At least 5 years of prior work experience in pharmaceutical environment.
- Prior experience working with Laboratory Management Systems
- Prior experience in Technical Writing. Important skills Understand Laboratory Validation, lab requirements, Lab electronic systems, change control process, risk assessment type evaluation
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.