Quality Assurance Specialist, Documentation and Training

Why Work With Us?

Location: Hybrid (Needham, MA office)
Salary: $92,000 - $100,000
 
Candel is a clinical-stage biopharmaceutical company developing innovative multimodal viral immunotherapies designed to harness the power of the immune system against cancer. With positive Phase 3 results from our lead program and BLA readiness underway, Candel is reaching an important inflection point—one that creates the opportunity to translate scientific innovation into meaningful impact for patients, while the company continues to advance the next generation of programs across solid tumors.
 
This is an exciting time for Candel as we evolve from a focused clinical-stage biotechnology company toward an integrated biopharmaceutical organization.
Our people are at the heart of that journey!  We believe breakthrough science is powered by people who challenge convention, bring different perspectives, collaborate across disciplines, and focus on shared outcomes.  Candel’s culture is grounded in trust, flexibility, accountability, creativity, and a shared commitment to one goal: improving the lives of patients and their families.


Position Summary:

Cross-functional to support relevant Quality Systems GXP activities in adherence to applicable regulations (FDA, EU, etc.) and standards (ICH Q10, ISO). Also supports the implementation and improvement of Quality Systems to ensure quality and adherence with current Good Manufacturing Practice (cGMP) and inspection readiness.

What You’ll Own

• Administers Document Management Program and provides support to end users for the creation, revision, and retirement of documents including: 
• • Reviews GxP documents and records for completeness and compliance with internal procedures and applicable regulations and ensures ALCOA++ principles are followed to ensure data robustness. 
  • Supports and manages document lifecycle in the Electronic Quality Management System (eQMS) 
  • Maintains and improves Document Management Program procedures 
  • Provides training on the Document Management Program 
  • Acts as Administrator for Document Management within the eQMS 
  • Manages physical document archival and retention program 
• Administers the Training Management Program and provides support to end users for the maintenance of training activities including: 
• • Maintains user roles, training curricula, and training assignments. 
  • Maintains and improves Training Management Program procedures 
  • Provides training on the Training Management Program, as well as Employe Onboarding Program related policies and procedures. 
  • Assists document owners in generating training materials and quiz questions 
  • Acts as Administrator for Training Management within the eQMS 
• Additional duties to include: 
  • Inspection readiness and support tasks, as assigned 
  • eQMS, validation support
  • Continuous Improvement initiatives 
  • Other responsibilities as assigned by management

 

Required Qualifications

Education: 

• BS/BA in a scientific or engineering discipline with 4+ years of experience in pharmaceutical/ biotech industry within Quality Assurance, Quality Assurance exposure, or equivalent experiences.

• Or, Associate’s degree in a scientific or engineering discipline with 6+ years of Quality experience or Quality (Assurance) exposure or equivalent experiences

Experience: 
 

• Strong knowledge in 21 CFR Part 11, Annex 11, CFR 210, CFR 211, GXP practices.

• Knowledge of ICH Q7, Q9, Q10 guidelines.

• Regulatory inspection exposure/experience.

• Internal and external company 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.
• Ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.

• Proficient in Microsoft suite (Word, Excel, PowerPoint, Access, and Outlook).

• Familiarity/experience using Smartsheet.

• Excellent written and oral communication skills.

• Ethical, self-motivated and self-directed

NOTE: All applicants must be authorized to work in the U.S. and not require sponsorship. Unfortunately, we are unable to provide sponsorship of any kind at this time.