Quality Assurance Specialist (Contract)

Technical Services San Jose, California


Description

Position at Kymanox

Is Kymanox the right fit for you?    
     
     You want to make a difference and have an impact…    
     You enjoy having an influence in your day to day work…    
     You are motivated by working alongside a team filled with     
                  subject matter experts that will help you learn and grow…    
     You wake up every day and do what you do    
    
            … because patients deserve better.    
     
If this sounds like you, you’ve come to the right place.
      
Kymanox is hiring a Quality Assurance Specialist (Contract) on-site with our client in San Jose, California.
      
Primary Responsibilities:
  • Perform investigations per established procedures
  • Support problem solving and troubleshooting as part of investigations
  • Generate quality records as needed (CAPAs, CCs) to support process improvements
  • Review laboratory records (test packets, logbooks, etc.) and ensure they have acceptable Good Documentation Practices and are following procedures
  • Update and draft standard operating procedures and work instructions
  • Communicate effectively with all team members
Minimum Qualifications:
  • Bachelor’s Degree in a scientific, engineering, or other technical discipline
  • 4 years of experience in a quality assurance setting
  • Direct experience in record review, investigations, and root cause analysis
  • Good understanding and compliance with principles of Good Documentation Practices
  • Strong organizational and time management skills
  • Excellent attention to detail
  • Strong analytical skills
  • Succeed when working independently and as part of a team
  • Demonstrated work ethic and accountability
Preferred Qualifications:
  • Experience working within a quality system (e.g. Veeva)
  • Thrive in a fast paced, growing, and dynamic work environment
        
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About Kymanox:     
   
Kymanox (‘ki-mah-noks’), meaning Ideal Knowledge Transfer, advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive.    
     
By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there.  We do all of this with heart and pride… because patients deserve better.    
     
Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany, Switzerland, and Israel.


Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.