Full-Time Quality Specialist

Overview

The Quality Specialist is an experienced quality assurance professional who is process driven. This individual possesses an ability to successfully implement and maintain efficient quality systems. The Quality Specialist works in a pivotal role maintaining Lightship’s comprehensive quality management system. This individual will engage with cross functional resources to ensure that all quality standards are being met and maintained. 

Given the distributed team model at Lightship, and the remote nature of this position, individuals must possess a willingness and desire to work independently without significant oversight. Additionally, this position may require mild travel – approximately 10%. 

The Quality Specialist is responsible for:

• Participating in the management of the comprehensive quality management system at Lightship 
• Acting as the business process owner for Lightship’s electronic document management system (eDMS), quality management system (QMS) and learning management system (LMS) by providing operational and administrative support and ongoing training to end user 
• Identifying and assessing the training needs of the organization and administering company and GCP training 
• Assisting in the preparation for Quality Management Reviews (QMR), including compiling and reviewing relevant quality key performance indicators (KPIs) and participating in the execution of QMRs 
• Supporting internal audits of GCP functional areas, client audits and/or regulatory inspections by running the audit/inspection support room (e.g., retrieve records upon request, manage Slack (or similar) channel, maintain daily logs of document request) as required 
• Assisting in vendor qualification and re-qualification, including supporting with the preparation and execution of vendor audits  
  
  
• Contributing to the review and management of deviation investigations and Corrective and Preventive Actions (CAPAs) and Effectiveness Checks (ECs)
  
  
  
•  Contributing to the creation and maintenance of quality related SOPs, policies, and related training 
• Acting as a Quality SME in cross-functional process improvement activities 
• Review and approve computerized system validation deliverables including but not limited to Change Control Records, Validation Documents, Requirements Risk assessment, User Requirements, Part 11 Assessments, etc.  
• Other duties as assigned 

The Quality Specialist has:

• Required knowledge, skills, and abilities:
  • Excellent oral and written communication skills 
  • Thorough knowledge of International Conference on Harmonization (ICH) / Good Clinical Practice (GCP) guidelines and regulations 
    
    
  • Ability to work cross functionally
    
    
  • Ability to prioritize and successfully manage multiple tasks 
    
    
  • Ability to maintain flexibility and to adapt in a fast-paced environment
    
    
  • Exceptional attention to detail 
    
    
  • Superior time management and organizational skills 
    
    
  • Web and computer skills, including advanced knowledge of Microsoft Office Suite
     
• Education and experience:
  • Bachelor’s degree in Life Science/healthcare 
  • 2+ years of experience in a quality assurance function or equivalent experience in a role with quality and/or compliance responsibilities  
    
    
    
  • 2+ years of experience within clinical research, biologic, biopharmaceutical, or regulated pharmaceutical industry 
    
    
    
  • Previous experience using and/or managing an electronic document management system/quality management system, MasterControl experience preferred 
    
    
    
  • Requisite combination of education, training, and experience