Quality Intern

See Yourself at Telix

A Quality Management System (QMS) is essential for ensuring that an organization consistently meets customer and regulatory requirements while enhancing overall performance.  The Quality Intern role will be focused on document management within the Telix QMS utilizing Master Control (MC).  The following focus areas will be:

• Doc Control Framework
  • Structure: Leverage MC folder structure to manage location of key GMP documents
  • Approval Process: Identify appropriate Work Flows within MC for Documents and assure they are being followed for key GMP documents.  Leverage and streamline uploading of documents approved outside of MC
• Accessibility
  • Centralized Repository: A digital document management system that is easily navigable, allowing staff to locate and retrieve documents quickly.
  • Search Functionality: Leverage/create key advanced searches to find commonly requested documents using keywords, folder structures, or categories
• Regular Review and Updates
  • Scheduled Reviews: Periodic evaluations of documents to ensure they remain relevant and accurate, incorporating feedback from users.
  • Change Management: Utilize established formal process for managing changes to documents, including impact assessments and communication plans when needed.
• Feedback Mechanisms
  • Customer (Mfg, Reg, QA) Feedback: Solicit feedback from users to improve document clarity, usability, and relevance.
  • Continuous Improvement: Use feedback to make ongoing enhancements to the document management processes.

The Quality Management will interface with QA, Manufacturing, and Regulatory Affairs staff to assure key GMP documents are appropriately managed in Master Control as the Central GMP repository.

Main Duties and Responsibilities may include, but are not limited to:

Key GMP documents must be managed with appropriate controls to assure accessibility, security, data integrity, and reliability.  Currently, these documents reside in multiple locations (Master Control, Sharepoint, One Drive, Teams, etc.).  Key GMP documents must be maintained within Master Control per Telix SOP-0106:

• Develop clear understanding of Document Management structures in Master Control
• Coordinate and organize documents needing to be uploaded/approved in Master Control with key business partners in Manufacturing, Logistics/Supply Chain, and Regulatory
• Interface with Master Control SME to update/provide improvement updates to Master Control
• Partner with Commercial QA SME to validate/audit document management updates
• Report weekly progress to Commercial QA Leader and make adjustments as needed
• Leverage Master Control tools and identify efficiency opportunities

Education and Experience:

• Completing Undergraduate Degree/Pharmacy Program
• Majoring in STEM preferred (e.g., Pharmacy, Chemistry, Statistics, etc)
• Knowledgeable in Microsoft tools (PP, XL, Visio, etc)
• Experiences utilizing other COTS (Commercial Of-The-Shelf) IT tools (e.g., SAP, Data Management, Databases, etc.)
• Strong verbal and written communication skills
• Ability to meet tight timelines
• Agility with fast moving, changing deliverables