Sr. Quality Management Systems Specialist

About the role

BioCryst is seeking a Sr. Quality Management Systems Specialist to ensure the Document Control System is maintained in compliance with BioCryst SOPs, Quality Systems, applicable cGMPs, and Regulatory requirements. This position also assists with administration of the BioCryst Training Program and supports the Vendor Qualification, oversight, and management process, ensuring daily operational vendor-related tasks are conducted in compliance with BioCryst SOPs, Quality Systems, applicable cGMPs, and Regulatory requirements.

Responsibilities

• 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, ComplianceWire, 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, including: assisting with provision of new user accounts, training, and support for ComplianceWire LMS; assisting with employee Training Program and periodic review of all training files; assisting with Training Curriculum updates for all employees, and maintenance of employee electronic training files; collaborating with internal departments to identify training needs; assigning and tracking training; serving as back-up ComplianceWire Organization Administrator; supporting training of internal departmental ComplianceWire Content Administrators; assisting with eDMS/QMS training sessions
• Supports the administration of the Vendor Management Program, including: reviewing GxP assessment schedules and communicating with internal customers in a timely manner to prepare for routine vendor reassessments; maintaining GxP tracker and Assessment Status tracker spreadsheets and shepherding assessments through the process according to priority and the assessment schedule; supporting change control processes related to vendor management (New Vendor Requests, Changes to Existing Vendor Requests, Vendor Re-Assessment, Vendor Risk Assessment, Vendor Summary, etc.); reviewing 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; supporting/providing input into vendor management-controlled documents and life cycle/retention procedures; performing proofreading, editing, word processing, and filing to support Quality Assurance Documentation used for vendor qualification/management; creating and maintaining filing systems for all vendor-related assessment documents and information; maintaining vendor-related documentation in electronic vendor folders; supporting the FAR and/or other Stakeholders as needed in completing vendor qualification documentation; facilitating timely review and discussion with internal vendor documentation reviewers as needed to resolve comments/questions
• Supports validation and implementation processes for Quality Systems
• Provides cross-functional support within QA department, as needed
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules
• Maintains an awareness of evolving industry standards for document generation and electronic document management
• Supports critical business meetings by managing presentation versions, meeting minutes, and action items
• Other duties as assigned

Qualifications

• Bachelor's degree preferred, or Associate Degree or equivalent plus five (5) years of pharmaceutical experience in QA Operations, Manufacturing, QC and/or other relevant operational areas required, or an equivalent combination of education and experience
• Possess strong technical computer skills with proficiency in using various computer programs and web-based applications, including Microsoft Word, Excel, PowerPoint, One Drive, SharePoint
• Experience with any Veeva environment is desired
• Results-oriented, with a strong work ethic and ability to manage and complete multiple projects with minimal oversight
• Strong analytical and problem-solving skills
• Strong organizational skills and attention to detail
• Ability to work successfully in a fast-paced, team-oriented environment
• Ability to maintain confidentiality and work with sensitive documents
• Adapts to changing priorities effectively
• Knowledge of FDA regulations and industry standard guidelines for electronic records; i.e., 21 CFR Part 11
• Demonstrate ethical conduct, focus on goals, take ownership of actions, and act in the best interest of the Company
• Knowledge of US FDA GMP requirements and associated guidelines