MasterControl eQMS Admin – Compliance & Validation Lead

LifeScience Logistics LLC.; Dallas (TX); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

LifeScience Logistics LLC is seeking an experienced MasterControl Administrator to configure and maintain MasterControl modules across documents, training, CAPA, and audits. You will manage users, monitor system health, and coordinate upgrades while supporting asset management, calibration, and vendor relationships.

You will work closely with Quality to author validation deliverables, maintain 21 CFR Part 11 compliance, and serve as SME during audits.

Qualifications

• Bachelor's degree in life sciences, information systems, computer science, or related field, or equivalent experience.
• 3–5 years hands-on MasterControl experience administering eQMS in FDA-regulated environment (pharma/biotech/medical device/pharma logistics).
• Experience administering MasterControl asset management module (Asset Excellence) or equivalent CMMS for regulated equipment.
• Knowledge of 21 CFR Part 11, 21 CFR Parts 210/211, and computer system validation practices.
• Hands-on experience authoring/executing validation docs and managing system change control.
• Experience supporting regulatory or customer audits as system SME.
• Clear, concise written and verbal communication; ability to write requirements, test scripts, SOPs.
• MS Office proficiency (Excel, Teams, Outlook, Word, PowerPoint).
• On-site work at Corporate Headquarters in Dallas, TX.

Responsabilités

• Configure and maintain MasterControl modules: documents, training, quality events, deviations, CAPA, change control, audits.
• Manage user provisioning, deprovisioning, and annual access reviews.
• Monitor system health, plan version upgrades and patches.
• Provide tier 2 support; own backlog and escalate to vendor with root cause.
• Administer asset management: records, maintenance schedules, calibration, service requests, vendor management.
• Keep asset records and maintenance history audit-ready linked to quality events.
• Define asset categories/statuses and report overdue calibrations/maintenance.
• Partner with Quality for validation deliverables and ensure 21 CFR 11 compliance; audit support.

Connaissances

Regulatory awareness

Communication

Problem solving

Team collaboration

Formation

Bachelor's degree in life sciences/IS/CS

Outils

MasterControl

MasterControl Asset Excellence (Qualer)

CMMS

SQL

APIs / SSO

Description du poste

LifeScience Logistics LLC is seeking an experienced MasterControl Administrator to configure and maintain MasterControl modules across documents, training, CAPA, and audits. You will manage users, monitor system health, and coordinate upgrades while supporting asset management, calibration, and vendor relationships.

You will work closely with Quality to author validation deliverables, maintain 21 CFR Part 11 compliance, and serve as SME during audits.