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Position Summary:
We are looking for a highly organized and technically proficient contractor to streamline and optimize our existing MasterControl Training Module. The ideal candidate will bring hands-on IT capabilities, a deep understanding of eQMS platforms-specifically MasterControl-and experience consolidating documentation and configuring training workflows. This role will focus on enhancing user experience, ensuring compliance, and building scalable training functions within the system.
Key Responsibilities:
- Assess the current state of the MasterControl Training Module and identify opportunities for optimization and streamlining.
- Consolidate training documents and associated information into a coherent, searchable, and compliant structure.
- Configure the training function in MasterControl to support role-based training, auto-enrollment, reminders, and escalation workflows.
- Set up and manage multiple info card types to support various training and quality documentation categories.
- Develop and implement scalable, intuitive solutions that reduce administrative burden and enhance system usability.
- Collaborate with cross-functional teams including Quality Assurance, IT, and HR to ensure the training module aligns with organizational and regulatory needs.
- Provide technical support and hands-on configuration within MasterControl including templates, workflows, user groups, and metadata.
- Assist in the development of SOPs and documentation related to system use, configuration, and training processes.
- Support the deployment of MasterControl training and onboarding materials for end users and administrators.
Qualifications:
- Proven experience configuring and managing MasterControl (preferably in a regulated industry such as medical device, biotech, or pharma).
- Strong understanding of eQMS systems, training module configuration, and document management.
- Experience with document consolidation and system optimization.
- Proficiency with configuring info cards, workflows, templates, and training hierarchies.
- Solid IT skills with the ability to perform hands-on configuration, troubleshooting, and user support.
- Strong communication and collaboration skills, with the ability to work independently and cross-functionally.
- Familiarity with FDA 21 CFR Part 11, ISO 13485, and other applicable regulatory requirements is a plus.
Preferred Qualifications:
- Experience supporting audits or validation of eQMS systems.
- Experience with or knowledge of CAPA Modules
- Background in instructional design or adult learning principles related to training system development.
- Previous experience as a contractor or consultant for quality system implementations.
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