logo

View all jobs

Quality Assurance Training Specialist

Needham, MA

Candel Therapeutics is a clinical-stage biotechnology company pioneering the development of viral based immunotherapies for the treatment of solid tumors. Candel’s products are designed to significantly help patients fight their cancer while maintaining quality of life – from early – to late-stage disease. 

Join our rapidly growing Company where you will work in an environment that values innovation, scientific rigor and a “can do” attitude. We care deeply about our team, our patients, and our community. We have a robust pipeline of investigational drug candidates in phase 1, 2 and 3 clinical trials in prostate, brain, lung, and pancreatic cancers. 

Please visit  www.Candeltx.com for additional information. 

Summary: 

This role will focus on the management of our training program. The successful candidate will work cross-functionally to develop and deliver training in support of GXP activities and adherence to applicable regulations and standards.  

Responsibilities: 

  • Own Candel’s training program and serve as a resource for departments across the company. 
  • Manage and administer training program activities using Candel’s QMS system, including the development of content and job aids. 
  • Create and modify user groups, training items, curricula, group trainings, and assignments. 
  • Assess metrics using Learning Management System (LMS) to identify training needs and improvement projects.  
  • Assist with employee “on-boarding” training on general and quality-specific procedural requirements. 
  • Support Document Control for workflow development and training issuance.  

Requirements: 

  • Bachelor’s degree with practical experience in a regulated manufacturing environment or equivalent experience. 
  • A minimum of 4 years of relevant experience required. 
  • Strong knowledge in 21 CFR Part 11, CFR 210, CFR 211, ICH Q10, GXP practices. 
  • Audit experience. 
  • Experience in electronic management systems, but not limited to electronic learning management system (e-LMS) and EDMS. 
  • Experience developing training plans and curricula is preferred. 
  • Highly motivated individual with excellent time management skills. 
  • Strong organizational skills with the ability to effectively prioritize and manage multiple projects and tasks with attention to detail. 
  • Ability to proactively resolve issues in a diplomatic, flexible, and constructive manner. 
  • Proficient in Microsoft suite (Word, Excel, PowerPoint, Access and Outlook). 
  • Excellent written and oral communication skills. 
  • Ethical, self-motivated and self-directed. 
Powered by