Quality Assurance Specialist - Remote

Company: Medable, Inc
Location: Saint Louis
Posted on: January 16, 2022

Job Description:

Company Description

Medable's mission is to get effective therapies to patients faster. We provide an end-to-end, cloud-based platform with a flexible suite of tools that allows patients, healthcare providers, clinical research organizations and pharmaceutical sponsors to work together as a team in clinical trials. Our solutions enable more efficient clinical research, more effective healthcare delivery, and more accurate precision and predictive medicine. Our target audiences are patients, providers, principal investigators, and innovators who work in healthcare and life sciences.

Our vision is to accelerate the path to human discovery and medical cures. We are passionate about driving innovation and empowering consumers. We are proactive, collaborative, self-motivated learners, committed, bold and tenacious. We are dedicated to making this world a healthier place.

Job Description

• Ensure company compliance with GxP requirements, company policies and procedures, ISO standards, and MDD/MDR requirements
• Interpret and comply with quality assurance standards
• Ensure adequacy of current quality assurance standards and recommend enhancements
• Document quality assurance activities, including, internal audits and CAPAs
• Support other departments with CAPA process, including, creation and follow through to completion, ensuring appropriate documentation is captured
• Analyze non-compliance issues to identify trends and propose resolutions
• Gather and organize statistical quality data
• Identify quality areas for improvement
• Report on results of quality activities
• Carry out appropriate corrective procedures from internal and external audits
• Ensure risk management procedures are utilized correctly
• Ensure ongoing abidance by industry regulatory and quality requirements
• Other duties as assigned
  Qualifications
  
  Skills & Experience:
  
  • 3+ years of experience in a quality role or a combination of education and experience
  • Experience working in a quality capacity (pharmaceutical or medical device preferred)
  • Experience working in an ISO environment (preferred)
  • Ability to handle sensitive information with the highest degree of integrity, discretion and confidentiality
  • Analytical, problem-solving, and decision-making skills
  • Comfort working across teams in a fast-paced environment
    Minimum Level of Eduction:
    
    • Bachelor's degree in a related field
      Preferred Degree/Certification:
      
      • Six Sigma Green or Black Belt
      • ASQ Certified Auditor
        Additional Information
        
        Medable, Inc provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
        
        U.S. employees and contractors, and International workers with travel to the U.S. must have a willingness and ability to provide proof of completed COVID-19 vaccination prior to start date. All religious, medical, or other legally recognized exemptions regarding vaccination status will be considered.
        

Keywords: Medable, Inc, St. Louis , Quality Assurance Specialist - Remote, Other , Saint Louis, Missouri