Securabio

Securabio

Manager, Document Control and Training

Remote (United States) · Full-time

Sponsorship not specified$121k-$142kDetected 16 days ago
AuditingVendor ManagementControlsFDA RegulatoryMedical DevicesCommunicationMicrosoft OfficeGxPRegulatory Affairs

About the role

  • Global Quality, Regulatory Affairs, and Clinical Compliance.
  • System administration activities such as creating, monitoring and maintaining Users, Groups and Roles, and Entities (e.g., workflows) within the ACE system.
  • Record Archival in Ace: Ensuring GxP records are stored in the ACE system.

Responsibilities

  • About the Role The Manager of Document Control and Training is responsible for overseeing the document control and training processes and ensuring strict adherence to corporate policies, procedures, and applicable standards and regulations across all company quality systems.
  • This position will support Secura Bio, Inc.
  • Employment Type Full-time Reports To Senior Director, Quality Assurance Key Responsibilities Manage and oversee day-to-day operations and lead continuous improvement efforts in the Quality Management System (QMS), including Document Change Control, Document Control, and Training, to support GxP compliance across multiple areas.
  • Responsible for supporting and overseeing Document Control activities for documents used in GxP operations (includes manufacturing, clinical, regulatory, and product quality related documents) and archiving activities.
  • Facilitates and supports the creation, revision, and obsolescence of GxP controlled documents, to include reporting, periodic review, and trend analysis.
  • Support onboarding of new employees in Quality Management System.

Requirements

  • Ability to multi-task and prioritize projects to achieve established goals and objectives.
  • Ability to balance and prioritize multiple projects, duties, and assignments.
  • Ability to adapt to a fast-paced, team-oriented work environment.
  • Ability to promote cooperation and teamwork among team members.
  • Ability to analyze, troubleshoot, and resolve problems/issues as they arise.

Compensation

  • $121k-$142k
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This listing is sourced directly from Securabio's careers page and normalized into a canonical job model.