Lead Manufacturing Associate (Consumables) – All Shifts

Published
November 25, 2021
Location
Fremont, CA
Category
Job Type

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.

In this role, you will have the opportunity to:

  • Learn and notify supervisor of any violations of company safety policies and practices.

  • Maintain safe and clean work environment by leading by example and assisting supervisor in monitoring the use of all control points, equipment, and resources; maintaining compliance with established policies and procedures.

  • Adhere to, train and help to enforce compliance to GMP, ISO, Environmental, Health and Safety procedures. Participate in production tours and audits.

  • Work with Supervisor/Manager to review and provide feedback on schedule adherence to production schedules.

  • Monitor and provide updates on priority Lots.

  • Complete production plan by accomplishing work; monitoring progress; reporting results of the processing flow on shift production summaries.

  • Coordinate specific activities and assignments of work center resources to meet goals and objectives, production schedules and Core Metrics.

  • Assign daily tasks to support production requirements, new product development and support activities.

  • Help to coordinate set-up and changeover of manufacturing equipment

  • Assist in the preparation of production schedule, verification of component readiness, line clearances, and equipment readiness.

  • Assist in monitoring any in-process controls and test yields to ensure manufacturing process are operating within approved specification limits.

  • Assist in reviewing and completing all documentation accurately and help to ensure work center documentation is compliant with GMP requirements.

  • Help to ensure work center cleanliness and maintain Visual Workplace standards.

  • Interact with material planning team to meet the production plan.

  • Work with Production, Engineering and Quality teams to investigate and resolve any quality or non-conformance issues.  Initiate, investigate and oversee approval of Instrument related NCR’s.

  • Based on each Employee’s Training Plan, ensure Employee Training is completed.

  • Assist supervisor in proactively identifying and resolving potential issues/discrepancies and notifies supervisor.  Resolve routine issues.  Work with supervisor to resolve issues of moderate complexity.

  • Foster a collaborative work environment within and across departments including QC and engineering. 

  • Step in as required on to the Manufacturing Floor for employees not present in production; first ensuring training record is updated.

  • Ensure operation of equipment by calling for repairs

  • Assist supervisor in resolving personnel problems by analyzing data; investigating issues; identifying solutions; recommending action.

  • Support Lean Manufacturing initiatives.

  • Provide recommendation to supervisor in selecting employees for recognition and reward for positive impact to the team and organization.

The essential requirements of the job include:

  • Manufacturing or Production related experience.

  • High School diploma/GED or equivalent experience.

  • Preferably 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 or Kema audits.

  • Must be able to lift 25 lbs.

  • Must be able to stand for several hours.

  • Work may involve repetitive arm/wrist motions.

  • Ability to work directly with, handle or have contact with chemicals or re-agents.

  • Ability to read drawings.

  • Understand Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP).

  • Must be a team player and able to demonstrate the willingness and the ability to provide assistance to co-workers.

  • Ability to clearly and effectively communicate with peers, supervisors, manufacturing engineers, stockroom managers and leads.  Ability to understand 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.

  • Ability to solve basic math problems.

  • Able to identify each station of the machinery.

  • 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.

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 fully 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 [Click Here to Email Your Resumé] to request accommodation.

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

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