Document Control Specialist

2 weeks ago


Pomona, California, United States PSC Biotech Full time
About the Role

PSC Biotech is seeking a highly experienced Document Control Specialist to join our team. As a key member of our quality assurance team, you will be responsible for administering and maintaining our document control system to ensure all documents are up-to-date, compliant, and properly managed.

Key Responsibilities:

  • Administer and maintain the document control system to ensure all documents are compliant and properly managed.
  • Supervise the creation, review, approval, revision, and archiving of controlled documents in line with company policies and regulatory standards.
  • Ensure document version control and manage regular reviews of controlled documents.
  • Collaborate with various departments to ensure timely updates, revisions, and approvals of documents.
  • Oversee the training program to ensure all employees receive necessary GxP and SOP-related training.
  • Monitor and document employee training records, ensuring all training activities are completed and accessible for audits or inspections.
  • Maintain compliance with regulatory requirements by keeping training records accurate and up-to-date.
  • Prepare training records and document control systems for regulatory inspections, internal audits, and customer audits.
  • Provide documents and training records for audits and inspections as needed.
  • Work closely with other functional areas to ensure smooth integration of document control and training activities into daily operations.
Requirements
  • 23 years of experience in document control and/or training roles within a GxP-regulated environment.
  • Proficient in using document control systems and training platforms, with a preference for experience in Veeva Quality Docs and ComplianceWire systems.
  • Well-versed in GxP regulations, ISO standards, and regulatory compliance.
  • Exceptional organizational and time management abilities.
  • Keen attention to detail with the capability to handle multiple tasks simultaneously.
  • Strong communication and interpersonal skills for effective cross-departmental coordination.
  • Skilled in using document management software and learning management systems.


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