Quality Systems Consultant

Planet Pharma; Burlington (MA); On-site; USD 96,000 - 138,000; Full time

Job summary

Planet Pharma in the Boston area seeks a Quality Systems Consultant for a 3-month engagement to support document management activities including policies, SOPs, specifications, and training administration. The role requires hands-on ZenQMS and Box GxP administration, strong GMP and data integrity background, and the ability to train system users on quality processes and tools.

This role offers a fast-paced environment and direct impact on quality systems.

Qualifications

• BS degree in Life Sciences or related field.
• At least 4 years of pharmaceutical quality assurance and GxP regulatory experience.
• Hands-on experience administering eDMS/eLMS/eQMS platforms.
• Experience with Box GxP and ZenQMS required.
• Knowledge of US/EU GxP and data integrity requirements.
• Strong written and oral communication skills.
• Ability to train system users and prepare SOPs and user guides.

Responsibilities

• Support document management activities including policies, SOPs, specifications, and training administration.
• Administer ZenQMS and Box GxP daily, ensuring compliance and data integrity.
• Provide eQMS training and guidance to system users and stakeholders.
• Develop and deliver training presentations and quality metrics to management.

Skills

ZenQMS

Box GxP

GxP training

Document control

eDMS

eQMS

GMP compliance

Data integrity

Training delivery

SOP writing

Education

BS Life Sciences

Tools

ZenQMS

Box GxP

Job description

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.

Must-Have (Non-Negotiable)

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

Qualifications

• 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.