- Executes the initiation, processing, routing, distribution and archiving of cGMP documentation and directs the compliance of Leiden CTF documentation
- Support issuance, reconciliation, and archival of records for the Leiden CTF
- Provides direction on the document change control business process for Leiden CTF to stakeholders and customers
- Provides end user support/training on the Electronic Document Management System.
- Serves as a subject matter expert for the electronic document management system to internal and external clients
- Conducts user training on the electronic document management system
- Supports document control-related continuous improvement initiatives
- Supports drafting of departmental procedures in alignment with global and site policies and procedures, as needed
- Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred
- A minimum of 2 years of relevant experience, direct document management experience in a regulated environment focused on product quality is preferred.
- Strong teamwork and communication skills and the ability to follow written and verbal instructions are required.
- Knowledge of cell therapy, biologics manufacturing or analytical testing is highly desirable.
- Familiar with and able to interpret relevant regulations, regulatory agency inspection expectations (e.g. FDA, EMA, etc.) is required.
- Excellent computer skills and knowledge of MS Office and Document Management system is required.
- Direct experience with, and technical knowledge of, the administration of an electronic document management system (e.g. Veeva Vault, Documentum) in a relevant industry.
- Experience in providing guidance on compliance issues
- chain/cryogenic technologies
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Specialist, Document Control - Leiden, Nederland - Bristol Myers Squibb
Beschrijving
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb Netherlands
Bristol Myers Squibb has been active in the Dutch market for over 50 years, employing people across a range of activities and business units in Utrecht, The Netherlands.
The Netherlands is also home to our first European Cell Therapy facility, located at the Leiden Bio Science Park, the largest life sciences cluster of The Netherlands. This new state of the art facility is focused on commercial manufacturing with capabilities for multi-product Cell Therapy manufacturing. You can become part of this exciting journey. if you want to know more about it
The Netherlands has everything it takes to become the medicines hub of Europe, the so-called Boston by the North Sea. As we continue to expand our footprint by building this new site, we are looking to grow our team.
Would you like to become an important chain in our worldwide network to bring this new personalized treatment to patients suffering from blood cancer? Join us and be a game changer
Position Summary
This individual will be responsible for executing the initiation, processing, routing, distribution archiving of cGMP records for the Leiden CTF. The role of Specialist Document Control is stationed in Leiden and reports to the Senior Manager of Document Control for the Leiden CTF.
Key Responsibilities
Experience:
Disclaimer: For any third parties or external agencies, please, be informed we do not accept unsolicited requests, proposals, applications or profiles for any of our roles at BMS.
Why You Should Apply
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through scienceTM ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
