Document Control Associate

San Diego, CA

  • We are seeking a responsible, dynamic, creative and highly motivated Document Control Associate to join our Quality Assurance department.
  • The Document Control Associate will support the day-to-day maintenance of Samumed’s Quality Management System (“QMS”).
  • The position requires high attention to detail and past experience in document control, paper and electronic document management systems, and electronic training systems.
  • Under the supervision of the System Owner, the Document Control Associate will assist with promoting QMS adoption across the organization to increase regulatory compliance and data integrity. 
  • This is a full-time position in the company’s San Diego headquarters. 

Specific Responsibilities

  • Assisting in the coordination of the document control function to ensure version control, traceability/logging, and location/security of documents, including electronic (and paper, if applicable) archival/systems management
  • Reviewing, logging, and archiving both paper and electronic quality documentation to verify completeness, legibility, formatting, grammar, etc.
  • Managing the QA department’s electronic QMS, including the transition from any paper-based systems to the electronic-based system
  • Performing document archiving in both paper- and electronic-based quality systems according to the company’s retention policy.
  • Running reports on various quality system metrics for QA and site management
  • Coordinating logistics of the change management program for controlled documents, and assisting in the change management program for product and IT changes
  • Assisting in and/or performing as lead for document logistics during regulatory inspections (e.g., retrieval, copying, logging, review, notifications, scribing)
  • Participating in the development and delivery of internal training programs; ensuring training of internal staff
  • Assisting with the maintenance of QMS work instructions and SOPs
  • Coordinating the rollout of additional QMS features
  • Participating in cross-functional teams to ensure QMS success
  • Maintaining the GxP state of the QMS by authoring, executing, and reviewing validation and change control documentation
  • Maintaining QA vendor files
  • Assisting in the management of the internal GXP training program, as well as the quality training of contractors and/or consultants (new hire orientation, management of paper and/or electronic training files, reporting of training compliance to QA and cross-functional management)
  • Other various QA tasks as assigned

Requirements

  • High school diploma or equivalent (BS/BA in a relevant field preferred)
  • Strong verbal and written communication skills are essential
  • Exceptional interpersonal skills and problem solving capabilities
  • Experience working with an electronic QMS preferred
  • Basic knowledge of a programming scripting language or report writing a plus
  • Ability to successfully manage a full workload across multiple-projects
  • Excellent organizational and multi-tasking skills
  • A flexible attitude with respect to work assignments and continued industry related education
  • Ability to work independently and prioritize with minimal daily instruction
  • Ability to think strategically in order to improve current processes
  • Demonstrated analytical skills and extremely high attention to detail
  • Advanced functional experience in the following computer applications:
    • Microsoft Word
    • Microsoft Excel
    • Powerpoint
    • Acrobat Pro

Please submit your resume or additional inquiries to apply@samumed.com