Manufacturing Documents Coordinator

  • Job Reference: 462845222-2
  • Date Posted: 2 January 2022
  • Recruiter: Cepheid
  • Location: Milpitas, California
  • Salary: On Application

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.This position is part of Cepheid Diagnostics and will be located in Sunnyvale, CA.*POSITION SUMMARY:*Perform documentation reviews and material transactions to ensure timely and accurate reviews and submission of device history records along with maintaining an accurate inventory.  Identify and make recommendations for new procedural and process improvements. Provide leadership and support in ensuring quality, lowering cost and improving productivity in production.*In this role, you will have the opportunity to:** Work with SAP and other inventory management system.* Perform material transactions in SAP and DHR. Review for release in compliance with standards for good manufacturing practices.* Monitor and provide updates on DHR review and release priority.* Perform Data entry (Raw materials, IPT spreadsheet).* Participate in Daily Management in reporting daily metrics.* Archive DHRs and convert into QA.* Log DHR errors and coordinate with production supervisors for corrections.* Ensure batch records are complete and accurate.* Identify and eliminate sources of inefficiencies.*The essential requirements of the job include* :* 2+ years of related experience.* High School diploma/GED or equivalent experience.* Experience in clean room assembly or Manufacturing in the medical device, pharmaceutical or biotech industry, or equivalent combination of education and experience.* Experience in FDA audits.* ** Understanding of GMP and Good Documentation Practice (GDP).* Knowledge of SAP ERP system.* Ability to clearly and effectively communicate with peers, supervisors, engineers, managers, leads and upper management. * Ability to understand any given instructions and batch records written and spoken in English.* Effective verbal and written communication skills.* Ability to pay close attention to detail.* Basic Computer Skills including Microsoft Excel.* Ability to solve basic math problems.* Ability to identify each station of the machinery.* Ability to contribute to the development of concepts and techniques required in the position.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 [](). 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 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@](mailto:applyassistance@) to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.