Global LMS Specialist — GxP & Data Integrity

Socket.dev

Bloomington (IN)

On-site

USD 75,000 - 110,000

Full time

4 days ago
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Benefits offered by this job

Day One Benefits
Medical & Dental Coverage
401(k) Retirement Savings Plan with 5%
Paid Holidays
Paid Time Off
Education Assistance Program

Job summary

Simtra BioPharma Solutions (Simtra) is seeking a Learning Systems Specialist to oversee day-to-day operation and support of the organization’s learning management platforms across GxP and non-GxP environments. This role ensures accurate configuration, reporting, and data integrity while maintaining inspection-ready training records aligned with global standards.

Collaborating with Global LMS System Owners, you will support training compliance execution, but not own regulatory interpretations or

Qualifications

  • Bachelor’s degree in information systems, Life Sciences, Quality, Business, or related discipline preferred, or equivalent.
  • 3–5 years of experience administering an LMS or similar regulated enterprise system in a GxP regulated environment.
  • Strong understanding of LMS configuration, training assignment requirements, and data integrity principles (e.g., ALCOA+) within a GxP regulated environment.
  • Experience ensuring training records are audit-ready and supporting regulatory inspections or audits from a system perspective.
  • Ability to interpret SOPs, training requirements, and regulatory expectations and translate them into system configurations and training assignment’s structure.
  • Strong attention to detail, and accountability for maintaining accurate, complete, and compliant training records.
  • Effective communication skills and ability to collaborate with Quality, training, IT, and site stakeholders.

Responsibilities

  • Manages the daily operation of multiple enterprise learning management platforms and determines operational priorities within the role’s assigned scope.
  • Evaluates business and learning requirements and determines the appropriate platform configuration within approved standards, including learner profiles, access, permissions, curricula, learning assignments, and reporting structures.
  • Owns the accuracy and ongoing maintenance of platform setup for curricula, learning paths, training matrices, recurring requirements, and role-based assignments within approved parameters.
  • Assesses the operational impact and priority of platform issues, enhancements, upgrades, integrations, testing, releases, and change requests and provides recommendations to designated system owners and stakeholders.
  • Maintains LMS data integrity, audit trails, and system records in accordance with GxP and data integrity principles.
  • Analyzes data quality issues, discrepancies, duplicate records, interface errors, and assignment exceptions; determines root causes and appropriate corrective actions within scope.
  • Generates and analyzes training compliance reports and supports retrieval and presentation of training evidence during internal audits and regulatory inspections.
  • Explains LMS functionality, workflows, and approved site level configurations during audits or inspections, as required to support audit and inspection activities.
  • Ensures inspection outputs are accurate, traceable, and aligned with approved system configurations.
  • Participates in LMS governance forums led by the Global LMS System Owner, providing site level operational input and feedback.
  • Supports continuous improvement of LMS processes, reporting on user experience within approved governance frameworks.
  • Escalates system risks, recurring issues, or potential compliance concerns through defined training compliance and Quality channels.

Skills

LMS administration
GxP compliance
Data integrity
Attention to detail
Cross-functional collaboration

Education

Bachelor’s degree preferred

Tools

LMS platforms

Job description

Simtra BioPharma Solutions (Simtra) is seeking a Learning Systems Specialist to oversee day-to-day operation and support of the organization’s learning management platforms across GxP and non-GxP environments. This role ensures accurate configuration, reporting, and data integrity while maintaining inspection-ready training records aligned with global standards.

Collaborating with Global LMS System Owners, you will support training compliance execution, but not own regulatory interpretations or

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