Document Control Specialist
2 weeks ago
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.
- 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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Document Control and Training Specialist
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