Laboratory Compliance Associate

at  Cepheid

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.
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The Laboratory Compliance Associate will be responsible for supporting the manufacturing and quality control labs which includes but not limited to cleanliness, organization, restocking inventory, regular audits for GLP/GMP compliance and process improvements.
The person in this position is expected to generate creative, practical, and functional ideas for process improvements, and facilitate these concepts into action with feedback from the manager.
This position is part of the Manufacturing Support team which supports the Cepheid manufacturing operations at the Solna site. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

THE ESSENTIAL REQUIREMENTS OF THE JOB INCLUDE:

• Bachelor’s degree in Life Science or Engineering with 0-2 years of related work experience or 3+ years equivalent work experience
• Being able to work 5-shifts including daytime, evening, night, and weekend.
• Fluency in Swedish and English

IT WOULD BE A PLUS IF YOU ALSO POSSESS PREVIOUS EXPERIENCE IN:

• Knowledge and/or hands on experience with GMP test sample collection and sampling.
• A 24/7 production and laboratory working environment, including modified shift times, overtime, and weekends.
• Must be able to follow cGMP, GLP, FDA and ISO standards.
• Excels in fast faced team environment, able to multi-task, highly self-motivated and goal oriented.
  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 danaherbenefitsinfo.com.
  At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
  At Danaher, 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.

• Keep manufacturing and laboratory environment and practices comply with guidelines set forth by company and regulatory agencies
• Maintain laboratory contamination, wastewater, and swab surveillance and decontamination program to ensure amplicons and other ANA (Amplifiable Nucleic Acids) contamination are prevented.
• Perform regular lab inspections, audits, analyze and report (i.e., Manufacturing) to ensure adherence to company policies, guidelines, SOPs, and Biosafety program.