Quality Assurance Specialist – 2 Positions

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.

The Quality Assurance Specialist positions are cross-functional to support relevant Quality Systems GXP activities in adherence to applicable regulations (FDA, EU, etc.) and standards (ICH Q10, ISO). They also support the implementation and improvement of Quality Systems to ensure quality and adherence with current Good Manufacturing Practice (cGMP) and inspection readiness.

Responsibilities:

  • Provide support of day-to-day operations of the Quality System department for both internal and external customers.
  • Participate in continuous improvement initiatives.
  • Review records and documents, for completeness and compliance with global regulations.
  • Generate standard operating procedures and/or guidelines to define and improve quality system functions.
  • Support and manage document lifecycle the Electronic Document Management System (EDMS).
  • Track and trend compliance paperwork (deviations, change controls, etc. both internal and external).
  • Support and lead training program activities and analyze compliance metrics using learning management system (LMS).
  • Assist with employee “on-boarding” training on general quality specific procedural requirements.
  • Ensure data robustness and maintain ALCOA.
  • Create and modify user groups, training items, curricula, group trainings and assignments.
  • Participate in audit activities.
  • Assist with preparation of QMS metrics.

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.
  • 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.

Interested candidates please submit your resume to careers@candeltx.com