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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.

This position is part of the Quality Assurance Department located in Logan, Utah and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

What you will do:

The CAPA Leader for Cytiva is responsible for successfully driving the CAPA program at the Logan, Utah site and will perform the following

• Provide quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and comply with government regulations, industry and OpCo standards.

• May be responsible for supplier selection & auditing, material qualification, material inspection and test, performance monitoring and supplier development as well as managing process and product non-conformances in line with company procedures.

• May conduct quality assurance tests to ensure product specifications are met. Review, investigate, resolve and report on quality discrepancies. D evelop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards.

• May monitor, investigate, and report on customer complaints. May lead audit and inspection preparation, resolution of audit and inspection findings.

• May obtain the necessary quality system certifications and licenses (e.g. ISO, CE) to support market release of new product development.

  Who you are: :

• Bachelor's degree from an accredited institution with 4+ years of experience or 7-10 years of experience may be considered in lieu of a degree.

• Serve as the CAPA process owner for the site and ensure CAPA compliance across the business through driving strategy, direction, management, and oversight of the site CAPA program.

• Responsible to ensure that the CAPA Policy and Procedure meet all applicable requirements and regulations, including but not limited to, FDA 21 CFR Part 820, ISO 13485, and ISO 9001.

• Lead the CAPA review board and ensure that CAPAs are completed appropriately and on-time.

• Serve as the deviation management software system (Veeva) CAPA process owner.

It would be a plus if you also possess:

• Minimum of 4 years of experience in a regulated industry, preferably medical device or pharmaceutical.

• Excellent communication and interpersonal skills required with ability to present complex and sensitive issues.

• Ability to collect metric data, analyze and create a representation, present findings to key stakeholders, and identify trends.

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.

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.