Position: QMS Specialist
Karyopharm Therapeutics is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.
The Quality Management System (QMS) Specialist will be responsible for managing the Quality Documentation Control system and its related processes, including coordinating the revision, review, and approval of SOPs and other GxP documents and ensuring compliance with applicable domestic standards and regulations. This role will also be responsible for maintaining the Karyopharm GxP Learning Management system, training matrices and records, issuance of training materials and the documentation of training events and qualification of GxP staff. The scope of activities includes, but is not limited to, document control function, including document login, tracking, processing, distributing, and archiving; processing QMS records such as events and CAPA; maintaining and facilitating the training program. Will support the compilation of QS metrics; and participating in internal audits and supporting external audits.
- Facilitate / execute document workflows in eDMS (Veeva)
- Identify and propose solutions to potential nonconformance(s)
- Manages document change requests for customers as needed
- Review / edit user documents for compliance with current templates and procedures
- Track and report status of documents/records in system
- Assign/issue employee training based on hiring manager-designated Learning Path(s)
- Create new Learning Paths in eLMS
- Facilitate training content review/revision/approvals
- Manage training matrices, employee training records
- Upload training content (including documents) into LMS for training completion
- Issue/manage user accounts for eLMS / eQMS
- Support the documentation and management of changes to electronic GxP systems
- Support the revision and/or creation of department specific procedures and work instructions
- BA or AD preferred
- Quality professional with 2-5 years of hands-on experience with document control process in biopharmaceutical industry.
- Experience with electronic document management system is a plus.
- Well-organized and detailed oriented, with strong verbal and written communication skills.
- Good computer skills with working knowledge of MS office, such as Word, Visio and Excel, Access and Adobe Acrobat professional.
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