Sr. Quality Management Systems Specialist

Overview

COMPANY:
Bio Cryst

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 have pursued the development of novel medicines with a focus on structure-guided drug design to create first-in-class or best-in-class oral small-molecule and protein therapeutics. Our Discovery Center of Excellence is in Birmingham, Alabama, with global headquarters in Durham, North Carolina and teams across multiple countries.

We foster a culture of engagement and accountability that rewards innovative thinking and achievement of key objectives. For more information, please visit our website at  or follow us on Linked In and Instagram.

Bio Cryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Bio Cryst is committed to complying with federal, state, and local laws.

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.

• 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 and communicates with internal customers in a timely manner to prepare for routine vendor reassessments.
  • Maintains GxP tracker and Assessment Status tracker spreadsheets and shepherds assessments through the process according to priority and the assessment schedule.
  • Supports change control processes related to vendor management (i.e., New Vendor Requests, Changes to Existing Vendor Requests, Vendor Re-Assessment, Vendor Risk Assessment, Vendor Summary, etc.).
  • Reviews documentation/information requirements to ensure completeness prior to finalization and closure of assessment.
  • Responsible for timely distribution of vendor assessment documents for internal review upon completion by the vendor.
  • Supports/provides input into vendor management-controlled documents and life cycle/retention procedures.
  • Performs proofreading, editing, word processing, and filing to support Quality Assurance Documentation used for vendor…