MasterControl Assistant Migration Lead Consultant

• 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.

Important Notice: Protecting Your Information
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.