Bachelor's degree in life sciences, information systems, computer science, or related field, or equivalent experience
3-5 years of hands-on MasterControl experience in an FDA-regulated environment
Experience administering MasterControl Asset Excellence or equivalent CMMS for regulated equipment
Knowledge of 21 CFR Part 11 and computer system validation practices
Experience with validation documentation and system change control
Ability to support regulatory audits as a subject matter expert
Strong written and verbal communication skills
Proficiency in MS Office and ability to work on-site in Dallas, TX
Responsibilities
Configure and maintain MasterControl modules for documents, training, and quality events
Manage user access and conduct periodic reviews aligned with HR processes
Monitor system performance and execute version upgrades
Provide tier 2 support and manage issue backlog
Administer asset management module and maintain audit-ready records
Collaborate with Quality to execute validation deliverables for system changes
Translate SOP requirements into configured MasterControl processes
Build dashboards for reporting on quality metrics and compliance
Partner with IT for system integrations and data migrations
Benefits
Comprehensive health insurance
401(k) plan with company match
Paid time off and holidays
Professional development opportunities
Flexible work hours and occasional remote work options
Full Job Description
Responsibilities
Platform administration (eQMS)
Configure and maintain the MasterControl modules in use at LSL (documents, training, quality events such as deviations, CAPA, and change control, and audits), including workflows, forms, roles, and security groups
Manage user provisioning, deprovisioning, and periodic access reviews, aligned with LSL's HR and identity processes
Monitor system health, performance, and vendor releases. Plan and execute version upgrades and patches
Provide tier 2 support, own the issue backlog, and escalate to the vendor with a clear root cause
Asset management (MasterControl Asset Excellence)
Administer the asset management module: asset and equipment records, preventive maintenance schedules, calibration schedules, service requests, and vendor management
Keep asset records, calibration certificates, and maintenance history audit-ready and linked to the relevant quality events, such as an out-of-tolerance investigation or CAPA
Define asset categories, status rules, and notifications with Quality and Operations, and report on overdue calibration and maintenance
Compliance and validation
Partner with Quality to author and execute validation deliverables for every release and configuration change: validation plan, requirements, risk assessment, test protocols, traceability, and summary report
Keep the system compliant with 21 CFR Part 11 and applicable GxP expectations, including audit trails, electronic signatures, and record retention
Run changes to the platform through formal change control and maintain validated-state documentation
Serve as system subject matter expert during FDA, state board of pharmacy, and customer audits, and respond to system-related findings
Process enablement and reporting
Translate Quality's SOP and workflow requirements into configured, tested MasterControl processes. Push back when a requested design creates a compliance or usability problem
Build and maintain dashboards and metrics (open CAPA aging, training compliance, overdue document reviews, overdue calibrations) for Quality and executive reporting
Support customer-driven requirements, such as contract-specific training or document obligations, so the system enforces them
Write and maintain SOPs, work instructions, job aids, and release notes. Train and coach end users and process owners
Integration and data
Partner with IT application and integration staff on connections between MasterControl and other LSL systems (identity, HR, WMS, LIMS) where they are in scope
Plan data migrations, archival, and decommissioning of legacy document repositories with documented data-integrity checks
Qualifications and Job Specifications
Required
Bachelor's degree in life sciences, information systems, computer science, or a related field, or equivalent experience
3 to 5 years of hands-on MasterControl experience administering it as an eQMS (documents, training, and quality events) in an FDA-regulated environment (pharmaceutical, biotech, medical device, or pharma logistics)
Experience administering the MasterControl asset management module (MasterControl Asset Excellence, formerly Qualer), or equivalent CMMS and calibration management administration for regulated equipment, with the ability to configure it independently
Working knowledge of 21 CFR Part 11, 21 CFR Parts 210/211, and computer system validation or computer software assurance practices
Hands-on experience authoring and executing validation documentation and managing system change control
Experience supporting regulatory or customer audits as a system subject matter expert
Clear, concise written and verbal communication; able to write requirements, test scripts, and SOPs
Proficiency in MS Office (Excel, Teams, Outlook, Word, PowerPoint)
Ability to work on-site at Corporate Headquarters in Dallas, TX
Preferred
Experience with a new MasterControl rollout or implementation, including requirements gathering, configuration, validation, data migration, user training, and go-live support (a significant plus)
MasterControl certifications or formal vendor training, or experience through a major version upgrade
Experience in a pharmaceutical 3PL, distribution, or supply chain environment, including GDP, DSCSA, and state licensing obligations
Experience with integrations or APIs, SQL or reporting tools, and identity platforms such as single sign-on
Microbiology, quality assurance, or related lab background that helps in reading quality event and investigation workflows
ASQ certification (CQA, CQE) or ISPE/GAMP 5 training
Experience with CAPA effectiveness checks and quality metrics reporting for leadership
Previous experience working with a lean team in a regulated industry, such as pharma, healthcare, government, or financial services
Additional Employment Requirements
Must be able to successfully meet all preliminary employment requirements (i.e., background check and drug screen)
Physical/Mental/Visual Demands
Work is light to medium in nature with frequent walking to perform assigned tasks.
Work is performed in office.
Must be able to safely conduct occasional lifting of 25 lbs.
Working Conditions
Activities occur in a typical office environment.
Standard business hours with occasional after-hours work for upgrades and audit support, and occasional travel to LSL distribution sites.
