About The Position

The Documentation, Learning & Quality Systems Analyst is primarily responsible for the administration and optimization of the Learning Management System (LMS) and Document Management System (DMS), while supporting the broader Quality Management System (QMS). This role contributes to maintaining GxP-compliant processes, ensuring training and documentation compliance, and supporting quality initiatives, self-inspections, audits and continuous improvement activities across the organization.

Requirements

  • Undergraduate degree is required (Science, Life Sciences, Quality, or related field preferred).
  • Well-versed with GxP regulations.
  • Minimum 1-3 years of previous experience working in GxP Quality and Compliance processes.
  • Minimum 1-3 years of experience working with Pharmaceutical Quality Systems like DMS, QMS and LMS.
  • Minimum 1-3 years of experience with Quality Management Systems (QMS) framework and activities related to Quality Event and Deviation Management, CAPA, Effectiveness Checks, Change Control, and Document Life Cycle Management.
  • Experience working with GMP. GDP, GCP regulations in Life Sciences or HealthCare setting.
  • Effective business writing and technical writing skills in writing policies, standard process documents, and work instructions.
  • Excellent organizational & critical thinking skills and proven attention to detail.
  • Ability to work with strict timelines and handle multiple priorities.
  • Flexible, adaptable, and able to work under pressure and convey a sense of urgency.
  • Demonstrated initiative, accountability, and problem-solving ability.
  • Excellent customer service skills to address queries from internal and external stakeholders.
  • Team Player with the ability to function in a multi-disciplinary environment and promote collaboration.

Nice To Haves

  • Quality Certification or enrollment in quality education as part of continuous learning & development, is an asset.

Responsibilities

  • Manages training matrices and assigns training curricula in alignment with role-based requirements.
  • Administers training assignments, notifications, and escalations within the LMS.
  • Performs timely follow-ups with stakeholders to ensure training completion and compliance.
  • Monitors, analyzes, and reports training compliance metrics and KPIs.
  • Identifies trends, gaps, and opportunities for continuous improvement in training effectiveness.
  • Supports periodic review and optimization of training programs to ensure GxP compliance.
  • Supports the lifecycle management of controlled documents including creation, review, approval, issuance, revision, and archival.
  • Tracks and analyzes compliance with document review and approval workflows.
  • Performs document change control impact assessments in collaboration with the Quality team.
  • Maintains document repository integrity and ensures adherence to document control standards.
  • Supports QMS processes including change controls, QEs, CAPAs, training compliance, and document control.
  • Assists in monitoring QMS metrics and identifying meaningful trends for continuous improvement.
  • Supports the development, review, & maintenance of quality procedures (SOPs, POLs, WIs).
  • Proactively contributes to quality improvement initiatives and cross-functional process enhancements.
  • Maintains professional records (Job Descriptions, CVs, Organizational Charts) in compliance with GxP requirements.
  • Monitors and manages the LMS mailbox, addressing and escalating requests, as needed.
  • Supports audit readiness activities related to LMS, DMS, and QMS processes.
  • Supports administration and continuous improvement of LMS, DMS, and related QMS tools.
  • Performs other duties as assigned.
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