Document Control and Training Specialist
4 days ago
This is a remote position at PSC Biotech, a company that provides essential services to the life sciences industry.
We are passionate about bringing the best and brightest together to form something truly special. Our goal is to help our clients achieve success by employing a global team of skilled professionals and experts.
The Experience
With operations spanning the globe, we are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are looking for a Document Control and Training Specialist to administer and maintain the document control system, supervise the creation, review, approval, revision, and archiving of controlled documents, and oversee the training program to ensure all employees receive necessary GxP and SOP-related training.
Responsibilities
- Administer and maintain the document control system to ensure all documents are up-to-date, 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 (LMS).
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