Sr. Quality Management Systems Specialist

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type:
Full time posted on:
Posted Yesterday job requisition :
JR100085
** COMPANY:
*** At Bio Cryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we’ve been guided by our passion for not settling for “ordinary” in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama.

Our global headquarters is in Durham, North Carolina and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at
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* JOB SUMMARY:

**### The Sr. Quality Management Systems Specialist is responsible for ensuring the Bio Cryst Document Control System is maintained in compliance with Bio Cryst SOPs, Quality Systems, applicable cGMPs, and Regulatory requirements, and for assisting with administration of the Bio Cryst Training Program.### ### This position is also responsible for supporting the Bio Cryst Vendor Qualification, oversight, and management process, and will ensure that daily operational vendor-related tasks are conducted in compliance with Bio Cryst SOPs, Quality Systems, applicable cGMPs, and Regulatory requirements.
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* ESSENTIAL DUTIES & RESPONSIBILITIES:

*** Works to administer effective Quality Management Systems ensuring compliance to applicable internal procedures, cGMPs, and regulatory requirements, as follows:  + Serves as Document Control/eDMS/QMS administrator.  + Assists with provision of new user accounts, training, and support for Veeva eDMS/QMS  + Supports the review, update, filing and distribution of controlled documents, including standard operating procedures, standard test methods, protocols, summary reports, and technical documents according to specific Document Control format standards and guidelines.  

+ Creates and maintains controlled document templates.  + Ensures controlled documents conform with applicable procedures and are maintained to latest revisions; reviews formats for consistency.  + Responsible for timely distribution of draft and final controlled documents.  + Coordinates the approval process and orderly upload and filing of controlled documents to Veeva, Compliance Wire, and SharePoint, as applicable.  + Supports controlled document life cycle/retention procedures.  

+ Assists with Document Biennial Review Program.  + Performs proofreading, editing, word processing, and filing of controlled documents.  + Creates and maintains electronic filing systems for controlled documents.  + Maintains Master Content Lists and Tracking Sheets for SOPs, Policies, Work Instructions, Test Methods, Forms, and Templates.  + Assists with the preparation of quality metrics for QA for presentation to management.  

+ Assists with records retention and archiving, ensuring adherence to specific records retention schedules.  + Assists with document retrieval for internal audits and regulatory inspections.
* Supports the administration of the GxP Training Program as follows:  + Assists with provision of new user accounts, training , and support for Compliance Wire LMS.  + Assists with employee Training Program and periodic review of all training files.  + Assists with Training Curriculum updates for all employees, and maintenance of employee electronic training files.  + Collaborates with internal departments to identify training needs;

assigns and tracks training.  + Back-up Compliance Wire Organization Administrator.  + Supports training of internal departmental Compliance Wire Content Administrators.  + Assists with eDMS/QMS training sessions.
* Supports the administration of the Vendor Management Program as follows:  + Reviews the GxP assessment schedules…