Manager/Sr. Manager Document Control

DEPARTMENT: Quality Assurance
LOCATION: San Diego, CA
MANAGER: Director, QA
TYPE: Full Time, Permanent 

SUMMARY OF RESPONSIBILITIES: 

The Document Control Manager is responsible for managing GxP controlled documents for daily operations at Aptose throughout the development process by managing reviewers and approvers, adhering to strict timelines, and maintaining version control.

PRIMARY RESPONSIBILITIES: 

  • Manage and maintain controlled documents in the Aptose Electronic Document Management System (EDMS) including creating draft documents, assigning records, and linking supporting documents.
  • Prepare and revise SOPs and policies related to document control functions.
  • Serve as single point of contact for controlled document requests during due diligence, audit, and inspection activities.
  • Track Document Change Requests and Document Change Controls to ensure reviews and approval are completed within strict timelines
  • Coordinate the review, approval, and archival of Aptose‚Äôs controlled documents in accordance with GxP regulations.
  • Edit and proofread controlled documents for formatting, legibility, completeness, and adherence to templates and procedures.
  • Implement and utilize advanced word processing and automation features of Microsoft Office software
  • Develop reports within the EDMS to ensure accuracy and completeness of the document control process.
  • Participate in validation testing for system implementations and updates.

REQUIRED EDUCATION & WORK EXPERIENCE:

  • Bachelor's degree in a scientific or healthcare discipline.
  • Minimum of 5 years of professional work experience in Quality Assurance or Compliance document control.
  • In depth knowledge of document management and demonstrated ability to implement systems.
  • The ability to write policies and SOPs associated with document management functions.
  • Knowledge of GxP concepts and guidelines.
  • Strong written, oral, interpersonal and communication skills.

 PREFERRED QUALIFICATIONS: 

  • Experience in Hematology/Oncology (preferably non-solid tumor) clinical trials.

FUNCTIONAL / TECHNICAL KNOWLEDGE & SKILLS: 

  • Advanced experience using Microsoft Word, with an emphasis on document formatting
  • Experience with Adobe Acrobat
  • Experience using Microsoft SharePoint
  • Excellent attention to detail
  • Ability to work under tight deadlines and pressure while maintaining a high level of professionalism.
  • Demonstrated ability to perform detail-oriented work with a high degree of accuracy and completeness

COMPETENCIES:

  • Manage and improve process
  • Problem solving
  • Adaptable to changing priorities and competing demands
  • Teamwork
  • Collaborate
  • Communicate effectively in English, both oral and written
  • Deliver on commitments
  • Maintain composure
  • Proactively plan and organize
  • Be self-aware
  • Detail oriented and meticulous follow through
  • Facilitate
  • Influence and persuade
  • Lead
  • Manage and develop people

TRAVEL REQUIREMENTS: 

  • Minimal travel, as needed

Apply Now

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Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc