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Quality Systems Specialist III

Company: Cepheid
Location: Fremont
Posted on: November 17, 2021

Job Description:

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 procedures and quality system 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.
  • Perform and complete work with a moderate degree of supervision.
  • Support PDR closure, as needed.
  • Perform other duties, as assigned.TRAINING RESPONSIBILITIES: (REQUIRED)
    • Complete all assigned and required training satisfactorily and on time.MINIMUM REQUIREMENTS:Education and Experience (in years):--
      • High School degree (or equivalent experience) with 2-4 years of related work experience OR
      • AA or Technical Degree with 1-2 years of related work experienceKnowledge and Skills:--
        • Excellent verbal and written communication skills in group or one-on-one settings.
        • Ability to interface well with people of varied backgrounds, and to guide groups toward effective dynamics.
        • Understanding of general mathematical principles and calculations.
        • Understanding the general laboratory failure investigation, root cause analysis, and troubleshooting principles.
        • Computer skills: Microsoft Office: word, excel, access, power point, Microsoft project; Agile, SmartSolve, MES, and XpertERP.When 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 applyassistance@danaher.com to request accommodation.

          If you've ever wondered what's within you, there's no better time to find out.

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

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