Senior Failure Investigation Analyst

Wondering what's within Beckman Coulter? Take a closer look!

Join a team where you can be heard, be supported, and always be yourself. At Beckman Coulter, a Danaher company, we're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. At first glance, you will see we are dedicated to advancing and optimizing the laboratory to move science and health care forward for more than 80 years. Look again and see we're invested in you and give the ability to build a meaningful career, be creative, and try new things with the support you need to be successful.

Find the Danaher Business System, which makes everything possible. You will also see a company that investors trust-our culture of continuous improvement has helped us outperform the S&P 500 by more than 5,000% over the past 25 years.

And no matter where you look, at the heart of what we do, you'll witness our shared purpose-helping realize life's potential-in action. Our work helps improve millions of lives.

We hope you'll see yourself here, too.

What you find at Beckman Coulter -and within yourself - might just change the world!

The Senior Failure Investigation Analyst- Response and Corrective Action Team is responsible for the investigation of manufacturing and distribution non-conformances that may impact product quality at the Sacramento site. This role functions in a technical capacity to determine and limit any potential impact of quality non-conformances, recommends timely product dispositions, and implements corrective and preventative actions into manufacturing. This position supports stop ship and field action decisions, risk analysis, and the local audit program. Members of this team lead and support Operations validation and design change projects.

This position belongs to Microbiology Operating Company nested within Beckman Coulter and is located in West Sacramento, CA. At Microbiology as one of the world's leading ID/AST companies, our vision is to ensure that every patient has access to the right antibiotic treatment at the right time. You will be an integral part of the Microbiology Operations team.

If you thrive in a fast-paced setting, leading multi-functional teams and inspiring change describes you - read on.

In this role, you will have the opportunity to:

• Supports Internal Quality KPI-Leads and resolves Internal Non-conformance investigations (assessment of non-conforming product, corrective and preventative actions)
• Provide technical support for Operations (Design of experiments, technical writing, analytical testing (HPLC, UV-Vis Spectroscopy, and bioassay)
• Provide Operations project support (safety, cost, productivity, quality)
• Support Factory OTD of finished products
• Supports Operations validation and design change projects
• Lead and resolve customer manufacturing related CAPA (CAPA ARP and PRP, PLRA)
• Provide primary and secondary audit support
• Provide training and mentorship within operations

The essential requirements of the job include:

• Bachelor's degree in related science field with 5 years of experience, or
• Master's degree in related science field with at 3 years of experience, or
• Doctoral degree in related science field with 0-2 years of experience

It would be a plus if you also possess previous experience in:

• Non-conformance assessment, root-cause analysis, and CAPA
• Working with medical device quality systems in compliance with US FDA regulations (21 CFR) and ISO 13485
• Experience in Microbiology
• Risk management, process validation, design of experiments, and design change.
• Leading continuous improvement efforts, in a manufacturing environment.

Required Competencies:

• Exceptional communication skills (verbal/written/presentation/relationship building) with ability to work collaboratively with customers, cross-functional project teams.
• Ability to drive results, foster teamwork, handle pressure, and provide feedback
• Must be able to demonstrate skills in root cause investigation and problem solving
• Must show competency in high liquid chromatography (HPLC) and Spectrophotometry
• Must have critical thinking skills and good judgment working in an independent environment
• Organized and detail-oriented
• High level of initiative, self-motivation and energy.
• Reliable and responsive.
• Customer focused
• High level of integrity
• Goal oriented, interpersonal, self-motivated and team player

Sacramento is filled with opportunities whether you like metropolitan, suburban or rural lifestyles the area has all options available. It has a reasonable cost of living, abundant sunshine and ethnic diversity. The greater area has professional sports, museums and entertainment options with a unique blend of history of the West, not to mention easy access to every outdoor activity possible from sun and sand to snow. Sitting in the Central Valley, the metro area is at the forefront of the farm-to-fork movement. Residents have access to an abundance of fresh, locally sourced foods from nearby farms, wineries and breweries.

Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program, 401K savings plans, or paid time off; our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com. We believe you'll like what you see.

At Danaher, we're driven by a sense of wonder for what we can create-and what we can become. Here, you'll accelerate your career while driving innovation that improves lives. You'll work hard, with mentorship from committed leaders, powerful DBS tools, and the support of a global organization.

If you'd like to learn more, read stories from our associates on our Careers Blog or contact one of our recruiters.

Individuals who need a reasonable accommodation because of a disability for any of the employment process should call 202-419-7762 or email [email protected] to request accommodation.

When you join us, you'll also be joining Danaher's global organization, where 80,000 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.

Given the essential job duties of this position, the employee is required to be fully vaccinated against COVID-19 as a condition of employment, subject to reasonable accommodation and applicable 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 [email protected] to request accommodation.

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