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QA Sr. Manager, Document Control and Training SME

KPG99 INC
South San Francisco, CA Full Time
POSTED ON 1/21/2025
AVAILABLE BEFORE 4/21/2025

Position / Title :

QA Sr. Associate / Manager, Document Control and Training - Contract

Department : Location :

Hybrid, South San Francisco, CA

Position

Reporting to the Executive Director of QA, the Document Control & Training lead will be responsible for administering the Electronic Document Management System and Learning Management System, controlled document processing, assessing document related training requirements and tracking training. The Document Control & Training lead will ensure that document management and training programs are implemented and are effectively administered while maximizing efficiency, complying with industry standards, and achieving compliance targets. Additionally, this position should have sufficient knowledge and experience to establish and modify comprehensive document control systems which are compliant with cGMP, GLP, and GCP requirements.

Major Duties / Responsibilities

  • Manage the routine document control and training operations, including (but not limited to) ensuring appropriate document standards are developed and managed, workflows are processed, documents archived appropriately, training requirements for GxP employees are identified and completed, and new hires are effectively onboarded.
  • Manage the electronic systems supporting GxP documents and training.
  • Assist with validation of electronic systems and maintain them in a validated state.
  • Manage document archive of all internal GxP files.
  • Ensure all document control processes and retention of records are compliant with applicable QMS standards.
  • Define the policies / procedures for document control processes and company training programs.
  • Liaise with stakeholders regarding document approvals.
  • Create performance metrics for Document Control and Training
  • Write and revise Document Control and Training SOP’s. Assist with document workflows and processing for all SOPs.
  • Train, motivate and guide staff on the Document Control and Training processes.
  • Collaborate with Quality Assurance and operational teams to create training content for GxP staff.
  • Expected to be on site 2 days per week in the Star Therapeutics office in South San Francisco.

Skills & Abilities

  • Experience building and managing document management and training programs.
  • Working knowledge of Federal Regulations and Guidance Documents within life sciences industry.
  • Strong attention to detail, able to execute to aggressive timelines
  • Excellent verbal and written communication skills.
  • Good interpersonal skills with ability to interact with people at all levels with sensitivity and tact.
  • Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
  • Supervisor Responsibilities

    May supervise and or direct the work of outside workers, select site staff, and or professional consultants to deliver training, where needed.

    Education & Professional Experience

    Education

  • Bachelor’s degree preferred, but not required
  • Experience

  • Minimum of 3 years of related experience in Pharmaceutical or other regulated industry
  • Experience managing electronic and paper quality management systems, document control systems and learning management systems.
  • Previous experience in Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and / or Good Manufacturing Practices (GMP)) quality guidelines and FDA regulations including 21 CFR Part 11 / Annex 11.
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