Quality Compliance Audit Specialist - 1st Shift

Company: Cepheid
Location: Herald
Posted on: November 26, 2022

Job Description:

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges, driven by knowing that behind every test there is a patient waiting. Learn about the Danaher Business System which makes everything possible. The Quality Compliance Specialist is responsible for monitoring and documenting compliance activities related to Non-conformance report (NCR), Corrective and Preventive Action (CAPA). Also involve in reviewing procedures for compliance and participate in internal or external audit. This position is part of Cepheid Diagnostics and will be located in Lodi, CA on the 1st Shift, 7 am - 4 pm. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions. In this role, you will have the opportunity to:

• Provide support during internal audits to ensure that implemented process improvements and systems are successful and compliant.
• Provide assessment and monitor CAPA/NCR activities and other processes to identify and/or implement improvements.
• Support quality systems programs and processes by being a liaison to manufacturing with investigations into product or manufacturing processes.
• Assist with the creation and modification of Quality System procedures and related documentation. The essential requirements of the job include:
  • Bachelor's degree with 0 - 2+ years of related experience
  • Familiarity with the audit process via work experience, internship, or coursework It would be a plus if you also possess previous experience in:
    • 2+ years of quality/compliance experience
    • Familiarity with ISO 13485:2016 or FDA/QSR standards via work experience, internship, or coursework Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com. #L1-WT1 When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. - Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
      
      The EEO posters are available here.
      
      We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.
      
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Keywords: Cepheid, Sacramento , Quality Compliance Audit Specialist - 1st Shift, Other , Herald, California