What are the responsibilities and job description for the MasterControl Assistant Migration Lead Consultant position at MEDVACON LIFE SCIENCES, LLC?
This is a remote 1099 contract role.
Position Summary
The Assistant Migration Lead will support the rollout and ongoing management of the MasterControl electronic Quality Management System (eQMS) for the client. Reporting to the Project Lead, this role will assist with system configuration, operation, maintenance, and administration. Responsibilities include managing user accounts, roles, permissions, and workflows, supporting system upgrades and patches, troubleshooting issues, proposing enhancements, deploying updates, and testing and implementing new functionality. The role requires close collaboration with the CDMO client, MasterControl vendor teams, and internal stakeholders to ensure smooth system operation and rollout.
Key Responsibilities
System Implementation & Support
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com.
Powered by JazzHR
Position Summary
The Assistant Migration Lead will support the rollout and ongoing management of the MasterControl electronic Quality Management System (eQMS) for the client. Reporting to the Project Lead, this role will assist with system configuration, operation, maintenance, and administration. Responsibilities include managing user accounts, roles, permissions, and workflows, supporting system upgrades and patches, troubleshooting issues, proposing enhancements, deploying updates, and testing and implementing new functionality. The role requires close collaboration with the CDMO client, MasterControl vendor teams, and internal stakeholders to ensure smooth system operation and rollout.
Key Responsibilities
System Implementation & Support
- Assist in the validation, implementation, and configuration of MasterControl eQMS modules, including, but not limited to: Documents & Training, Supplier & Audit Mgmt., Change Control, Complaints
- Candidate should be versed in the MasterControl AQEM package, including AQEM CAPA, Deviations, and Management of Change.
- Support the setup and maintenance of Development, Test, Production, and Training environments.
- Assist with migrating data and document objects from legacy systems such as Documentum EDMS, ComplianceWire, and TrackWise.
- Ensure proper system configuration, integration with other systems, and go-live support.
- Provide post-go-live support, troubleshooting, and issue resolution.
- Act as an adjunct Business Analyst/Subject Matter Expert (SME) for QMS requirements.
- Collaborate with client business owners, project managers, MasterControl teams, and internal staff to align tasks, manage expectations, and support rollout.
- Develop and maintain installation, configuration, and change management procedures.
- Assist with workflow building, process improvements, and efficiency initiatives, especially within AQEM modules.
- Assist in developing validation strategies, artifacts, schedules, and execution tasks.
- Assist in creating, updating, and retiring user manuals, SOPs, work instructions, and training materials for all modules.
- Support identification and development of validation tasks, schedules, and artifacts per module.
- Provide technical guidance and training as needed, including support of system administrators, document administrators, and training coordinators.
- Daily administration of MasterControl, including user account management and maintaining the Master User List.
- Provide hands-on support for all system administration tasks, security roles, and permissions.
- Troubleshoot system issues for end users and liaise with MasterControl vendor teams as needed.
- Coordinate software and hardware changes following SDLC best practices and Change Control policies.
- Minimum 5 years’ experience in MasterControl system administration in pharmaceutical/ CDMO, biopharma/biotech, or healthcare environments.
- Demonstrated experience in system deployment, solution configuration, and eQMS administration.
- Extensive background and use of MasterControl Supplier Quality modules and familiarity with the MasterControl AQEM package.
- Knowledge of user roles, security requirements, and validated electronic systems.
- Experience providing daily administration, support, and development of eQMS, Training, and Quality applications.
- Strong problem-solving and troubleshooting skills.
- Ability to interact effectively with stakeholders at all organizational levels.
- Energetic, self-motivated, organized, and able to thrive in deadline-driven, high-pressure environments.
- Proficient in Microsoft Word, Excel, and Outlook.
- Understanding of 21 CFR Part 11, EU Annex 11, GxP best practices, and FDA guidance on data integrity.
- Quality Assurance experience is beneficial.
- Bachelor’s degree required; advanced degree preferred.
- Prior experience as an analyst or administrator for electronic data management systems.
- Pharmaceutical industry experience required, with a CDMO background preferred.
- Experience with validated systems under FDA 21 CFR Part 11 preferred.
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com.
Powered by JazzHR
