Overview In this Quality Systems Consultant role at a small biotech near Boston, you will support GxP document management and training programs. You will own hands-on administration of critical systems like ZenQMS and Box GxP, helping maintain data integrity and compliant quality processes. You'll work with cross-functional teams to implement and train on standard documents, SOPs, and training materials. This is a three-month engagement with potential extension, offering impactful work shaping quality systems in a biotech environment.
Responsibilities- Support document management activities (policies, SOPs, specifications) and training administration
- Administer ZenQMS and Box GxP for daily use
- Manage eDMS/eQMS administration and training activities
- Prepare SOPs, work practices, and user guides for quality system requirements
- Deliver and develop quality system training presentations; communicate performance metrics to management
Key requirements- BS degree in Life Sciences or related field
- Minimum 4 years in pharmaceutical QA and GxP regulatory compliance
- Hands-on experience with eDMS/eQMS, eLMS; administering Box GxP and ZenQMS
- Working knowledge of US/EU GxP related to document management, training, data integrity, and quality systems
- Strong oral and written communication; ability to train system users; ability to create user guides
- strong communication
- presentation skills
- training delivery
- ZenQMS administration
- Box GxP administration
- eDMS/eQMS administration
