What are the responsibilities and job description for the Compliance and Auditing Officer position at Cytiva?
Be part of something altogether life-changing!
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.
The QA Compliance and Auditing Officer for Cytiva is responsible for leading customer and internal audits, handling all Quality systems questionnaires, and maintain QMS compliance with ISO 9001 and Cytiva QMS requirements.
In this role, you will have the opportunity to:
- Hosting and leading audits and maintaining the certification process for internal auditors.
- Completing and/or monitoring responses and corrective action for audits nonconformities with customer, certification body and plant area owners .
- Developing action plans with process owners for reported audits nonconformities.
- Review Quality Documents for compliance with ISO 9001 and Global Cytiva QMS requirements.
- Establishing and maintaining an effective CAPA system to ensure existing and potential cause of non-conformances are identified and addressed in a timely and effective manner.
The essential requirements of the job include:
- Bachelor’s degree in Life Sciences, with 3 years of experience in Quality
- Proficient with computers and software in windows-based environment required
- Working experience with ISO 9001 and knowledge of ISO 13485. ISO 9001 Auditor certification is preferred.
- Excellent organizational skills and ability to prioritize work based on criticality and business needs
- Excellent communication in both verbal and in writing.
It would be a plus if you also possess previous experience in:
- Knowledge of Veeva QMS and Magic systems.
- Strong knowledge of Quality Assurance principles and practices
The salary range OR the hourly range for this role is . 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. We may ultimately pay more or less than the posted range. 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.
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.
