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Production Laboratory Supervisor

Company: Cepheid
Location: Lodi
Posted on: January 15, 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 worlds 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, were working at the pace of change on diagnostic tools that address the worlds 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 Control Supervisor is responsible for working with operations at Cepheid to meet client requirements and cGMP regulations via Quality Control staff. This is also a great chance to lead a team.This position is part of the Reagent Manufacturing Department and will be located in Lodi, California.In this role, you will have the opportunity to:

  • Handle the Reagent Manufacturing department daily work activities including: Team schedule, ensuring training, general guidance of direct reports and across functional groups
  • Support development of analytical methods. Work in conjunction with other departments to develop, qualify, and transfer analytical methods as applicable.
  • Ensure maintenance of equipment qualification, calibration and maintenance.
  • Draft, review, and approve Standard Operating Procedures (SOP), sampling plans, specifications, protocols and reports related to product/processes, equipment, method, validation. This includes deviation investigation and reporting.
  • Develop and implement statistical tools for Quality Systems monitoring and review.
  • Identify and implement improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes.
  • Lead investigations for failures during testing; perform troubleshooting, process development or improvement activities.The essential requirements of the job include:
    • High school degree with 8+ years of experience or bachelors degree with 5+ years of experience
    • Thorough knowledge of cGMP regulations related to Quality required
    • Consistent track record in method validation / qualification and qualification of equipment / systems.
    • Experience in a Laboratory operations in high pace setting.
    • Experience with overseeing people and providing leadership.It would be a plus if you also possess:
      • Experience with regulatory requirements and audit readiness/inspections.Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether its a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com. When you join us, youll also be joining Danahers global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, youll 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 fully vaccinated against COVID19 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 youve ever wondered whats within you, theres no better time to find out.

Keywords: Cepheid, Lodi , Production Laboratory Supervisor, Healthcare , Lodi, California

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