This is a contract role until the end of July, with some possibility of extension.
Entry-level opportunity to gain more experience!
The QA Document Control Specialist II (TEMP) supports Quality Assurance functions focused on GXP documentation. The position maintains GLP document control and training systems.
• Maintain GLP document control system including preparing, updating, formatting, distributing, issuing, and tracking GLP documents.
• Maintain GXP record retention program for archiving raw data, archiving documents on site and managing off site QA documentation storage.
• Manage, distribution and reconciliation of laboratory notebooks
• Manage GXP training database and periodic reports
• Provide GXP training, as needed
• Trend and report QA Document Control information
• Perform other ·ob-related functions
- Working knowledge of EDMS (electronic document management system)
- Strong working knowledge of cGMP or GLP.
- Strong working knowledge of MS Word, Access, Excel and related databases. Excellent communication skills.
- The ability to work independently and as part of a team
· Bachelor Science (BS) degree or equivalent experience
· 1-3 years QA experience in Biotech/Pharma industry.
Keywords: Quality Assurance, Documentation, GLP