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Quality Systems Document Control Change Analyst Lead

Company: Cepheid
Location: Sunnyvale
Posted on: January 13, 2022

Job Description:

In this role, you will have the opportunity to:

  • Subject Matter Authority on all current change control workflows and processes.
  • Review and perform a daily quality audit of change orders processed by the Document Control Team Change Analysts in the Oracle/Agile PLM system to evaluate accuracy and conformance to required procedures and workflow configurations (e.g. change order and dedicated document and part item attributes.
  • Review records and documents for completeness and compliance with QSR, ISO and internal template and procedure requirements. Perform final incorporation of documentation revisions and pre-release preparation of the document files associated with approved change orders and ensure workflow activities are completed.
  • Provide timely responses, task fulfillment, solutions and answers to a wide variety of requests related to document control and change process activities received within an electronic Work Ticket system and via email and telephone from a rapidly growing and diverse group of associates employed locally and worldwide.The essential requirements of the job include:
    • High School Degree with 6+ years of related work experience or Associates or Technical Trade Degree with 5+ years of related work experience.
    • Confirmed understanding of Quality System Regulations (21 CFR Part 820, FDA cGMP) and ISO requirements (13485-2016).
    • Experience in compiling data to support metrics reporting and analyzing current processes.Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that give to our lives. Whether it s a health care program or paid time off, our programs supply to life beyond the job. Check out our benefits at danaherbenefitsinfo.com!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 to request accommodation.#Sunnyvale#LI-SS2When 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 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 .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. Associated topics: attorney, attorney corporate, compliance, corporate, internal, lawyer, legal affairs, legal department, llp, market

Keywords: Cepheid, Sunnyvale , Quality Systems Document Control Change Analyst Lead, Professions , Sunnyvale, California

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