Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cepheid, one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world’s most complex health challenges. Together, we bring MORE change to the world. Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Lab Compliance Analyst is responsible for ensuring that all laboratory operations and procedures are in strict accordance with both corporate standards and applicable regulatory requirements. This role additionally supports the maintenance of manufacturing laboratories by overseeing cleanliness, organization, and conducting routine audits to verify GMP/GLP compliance, as well as facilitating process enhancements. This position reports to the Director, Manufacturing, and is part of Biochip Manufacturing located in Newark, CA, and will be an on-site role. In this role, you will have the opportunity to: + Perform routine surveillance swabbing, testing, inspections, and audits to uphold product quality and ensure adherence to regulatory standards; + Oversee and audit GMP/GLP compliance in production laboratories which includes developing/maintaining accurate regulatory documentation, prepare comprehensive compliance reports for submission., identify and report instances of non-compliance, and partner with relevant teams to develop and execute corrective and preventive action plans. + Conduct laboratory maintenance activities such as replacing reagents and replenishing PPE supplies, act as the primary point of contact for outstanding laboratory issues or service tickets. + Lead facility and process improvement initiatives, along with various laboratory enhancement projects, ensuring that all required changes or modifications to processes or standard procedures are properly implemented. + Deliver training to new associates regarding laboratory maintenance standards and aid throughout laboratory expansion and renovation initiatives. The essential requirements of the job include: + Bachelor’s degree with 3+ years of related work experience or master’s degree in field with 2+ years of related work experience and, understanding of laboratories equipment. Travel, Motor Vehicle Record & Physical/Environment Requirements: + · Ability to travel: under 5% domestically to other manufacturing sites It would be a plus if you also possess previous experience in: + 2+ years of related work experience in an FDA/ISO regulated manufacturing facility, public health laboratory or similar institution including knowledge and familiarity with working in Biosafety Level (BSL1 and BSL2) laboratories and Class A and B laboratories. + Experience in a clinical diagnostic or medical device environment + Statistical, Lean, and Six Sigma training, cGMP/GLP experience is highly preferred Cepheid, a Danaher operating 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 Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) . The annual salary range for this role is $100,000 - $115,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . 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 (https://www.dol.gov/agencies/ofccp/posters) . 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. Operating Company: Cepheid