Quality Assurance Specialist

Company: Cytiva
Location: Logan
Posted on: January 16, 2021

Job Description:

Quality Assurance Specialist

Help us improve access to life-changing therapies that can transform human health
We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.
Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.

We are looking for a Quality Assurance Specialist to work with our expert Cell Culture team of nearly 7,000 employees across the world. Do you have a passion for quality? Then we would love to hear from you.

What you ll do

• Responsible for ensuing compliance in accordance with documented procedures for all aspects of operations as well as functional responsibility.
  
• Reviews production and quality documentation for adherence to Good Documentation Practices
  
• Requirements and performs final batch release of intermediate and finished product in a timely, compliant manner.
  
• Perform quality audits and internal audits with real-time coaching/mentoring and follow-up as needed.
  
• Ensures deficiencies discovered are addressed and corrected as needed.
  
• Review and approval of deviation cases and corrective and preventive action plans (CAPA) including the use of problem-solving tools (5-Why, Cause and Effect, etc.) and technical writing.
  
• Ensures process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product/process related documentation.
  
• Performs a broad variety of tasks in support of quality and production as assigned by the departmental manager
  
  Who you are:
  
  • Bachelor's degree from an accredited institution (high school diploma/GED with 2-4 years of relevant work experience may be substituted for education).
    
  • Demonstrated understanding or aptitude to understand regulatory requirements including FDA CFR 21 820 and ISO 13485.
    
  • Demonstrated proficiency in word processing, spreadsheet, and presentation software.
    
  • Strong interpersonal communication skills with the ability to effectively communicate and work inter-departmentally.
    
  • Ability to accomplish goals and work with minimal supervision.
    
  • Demonstrated understanding or aptitude to understand continuous quality/process improvement tools (5S, SPC, DMIAC, root cause analysis tools, etc.).
    
  • Positive, team-player that consistently goes above and beyond.
    
  • Maintains a positive attitude, is self-motivated, and works well independently and as part of a team.
    
  • Flexible schedule which will include consistently working weekends (Saturday/Sunday).
    
  • Quality Assurance experience in a regulated industry strongly preferred.
    Who we are:
    Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you ll feel right at home here. If you re flexible, curious and relentless, you ll belong. If you are excited about a global culture, this can be the place to further your career.
    
    Want to know more? Experience life at Cytiva on our Careers website, Instagram channel and LinkedIn page!
    
    Cytiva is a 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.
    
    Cytiva is part of the Danaher family of companies, a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world.
    
    Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.

Keywords: Cytiva, Logan , Quality Assurance Specialist, Professions , Logan, Utah