Master Control Administrator

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.

LifeScience Logistics is an equal opportunity employer. Candidates will not be hired based on their race, sex, color, religion or national origin. Reasonable accommodation available for individuals with disabilities. We proudly support the employment of veterans and welcome applications from protected veterans and all qualified applicants.

*No Agencies Please*