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Quality Systems Specialist III

Company: Cepheid
Location: Sunnyvale
Posted on: November 22, 2021

Job Description:

Make an immediate impact on a global scale!At Cepheid, leader in molecular diagnostics, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert-- System, we've taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications.The work we do every day will change patient care around the world! Be inspired knowing you're part of the team helping to diagnose the most challenging diseases. Learn about the Danaher Business System which makes everything possible.This position is part of the Quality and Regulatory Department and will be located onsite in Sunnyvale, CA. ESSENTIAL JOB RESPONSIBILITIES:

  • Review records and documents, for completeness and compliance with QSR and ISO requirements.
  • Review batch record to support release of raw materials, work in progress and final products. This includes reagents, components and instrumentation-related products.
  • Collaborate with other function teams to resolve batch record discrepancies or errors as it related to Good Documentation Practice.
  • Assist to improve standard operating procedure and improve quality systems functions.
  • Support the Material Review Board, for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation Report, as needed.
  • Support PDR closure, as needed.
  • May provide continuous improvement to the processes and procedures. MINIMUM REQUIREMENTS:
    • High School degree (or equivalent experience) with at least 6 years of related work experience OR AA or Technical Degree with at least 4 years of related work experience. Knowledge and Skills:
      • Understanding of general mathematical principles and calculations.
      • Ability to perform routine statistical applications, compiling data to support metrics analyzing current process.
      • Understanding the general laboratory failure investigation, qualification/validation process, root cause analysis, and troubleshooting principles.
      • Computer skills: Microsoft Office: word, excel, access, power point, Microsoft project; Agile, SmartSolve, MES and XpertERP. It would be a plus if you have:
        • Experience in DNA diagnostics or other medical devices
        • Experience in Kaizen, Daily Management (DM) and GEMBA.Cepheid, a Danaher 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 .Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, and results-oriented.Danaher is committed to competitive compensation that typically has key components including base salary, and variable annual incentive compensation based on personal and company performance.#LI-_TH12When you join us, you'll also be joining Danaher's global organization, where 69,000 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 require all US and Puerto Rico employees to be vaccinated against COVID-19 as a condition of employment, subject to reasonable accommodation as required by law.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 to request accommodation. If you've ever wondered what's within you, there's no better time to find out.

Keywords: Cepheid, Sunnyvale , Quality Systems Specialist III, Other , Sunnyvale, California

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