Job Title: QA Documentation Specialist
Job Number: 24509
Location: Needham, MA
We are seeking a contract Document Control Specialist to support 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 job-related functions
- Bachelor Science (BS) degree or equivalent experience
- 1-3 years QA experience in Biotech/Pharma industry.
- 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