What are the responsibilities and job description for the Training specialist position at PSC Biotech?
This is a remote position.
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients success and you can be a part of our team s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America Europe Asia and the Middle East we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multicultural team PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special.
When you make the decision to join our team 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 firm believers in coaching and developing the next generation of industry leaders and influencers. As such you will not only be offered compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.
At PSC Biotech® it s about more than just a job it s about your career and your future.
Your Role
- Administer and maintain the document control system (e.g. Veeva Quality Docs) to ensure all documents (SOPs work instructions quality manuals) are uptodate compliant and properly managed.
- Supervise the creation review approval revision and archiving of controlled documents in line with company policies and regulatory standards.
- 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 SOPrelated 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 uptodate.
- 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.
- Support crossfunctional teams by offering expertise on documentation practices and training requirements.
Requirements
- 23 years of experience in document control and / or training roles within a GxPregulated environment (such as pharmaceutical biotech or medical device industries).
- Proficient in using document control systems (e.g. electronic document management systems QMS) and training platforms with a preference for experience in Veeva Quality Docs and ComplianceWire systems.
- Wellversed in GxP regulations (GMP GLP GCP) 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 crossdepartmental coordination.
- Skilled in using document management software and learning management systems (LMS).
Last updated : 2024-10-18
