Quality Systems Consultant

A small biotech in the greater Boston area is looking to add a Quality Systems Consultant to its team for the next 3 months (with possible extension or conversion). In this role, you will support document management activities, including policies, SOPs, specifications, and training administration. The team uses ZenQMS for SOP and training management and is looking for someone with strong hands-on experience in the system.

For all other GxP documentation, the client uses Box GxP, so experience with that platform is also required.

• ZenQMS experience (used daily)
• Box GxP experience (used daily)
• GxP training administration
• Document control and eDMS/eQMS administration
• Strong GMP and data integrity background

• Minimum BS degree in Life Sciences or a related discipline.
• Minimum of 4 years of pharmaceutical quality assurance and GxP regulatory compliance experience supporting GxP document management and training programs.

• Hands-on experience administering electronic document management systems (eDMS), electronic learning management systems (eLMS), and/or electronic quality management systems (eQMS).
• Experience administering Box GxP and ZenQMS is required.

• Working knowledge of U.S. and EU GxP requirements related to document management, training administration, data integrity, and pharmaceutical quality systems.
• Strong oral and written communication skills.

• Ability to effectively provide eQMS training and guidance to system users.
• Ability to prepare standard operating procedures, work practices, and user guides related to document management and training quality system requirements
• Strong presentation skills, including developing and delivering training presentations and presenting quality system performance metrics to management.