Location: Marlborough,MA, USA
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 Documentation and Training Specialist Cytiva is responsible for documentation and training of the QMS within the Upstream and Fluid Management Business Unit.
This position is part of the Quality Assurance team located in Marlborough, MA. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
In this role, you will have the opportunity to:
+ Manage the QMS documentation process, including global /business unit documentation, strategy, compliance, administration of the eDMS, and audit needs
+ Lead and support all routine activities associated with the document change management system and manage the training process, including global /business unit /site documentation, strategy, compliance, administration of the LMS, and audit needs
+ Lead the end-to-end strategy (assessment, design, development, implementation, and effectiveness) for training or other solutions for QMS
+ Lead, manage, and support the development and use of reports in support of audits, manager accountability, and business partner requirements
Collaborate with Subject Matter Experts on the current learning needs and strategies, develop and maintain training plans and curriculum, as well as anticipating future training needs based on business requirements and opportunities for improvement
The essential requirements of the job include:
+ Minimum 5 years' experience in Quality Assurance Documentation and Training role with 8 minimum years' experience in a regulated industry
+ Bachelor's degree in applicable field or equivalent by experience in Quality in a similar, highly regulated industry
It would be a plus if you also possess previous experience in:
+ Insights in applicable ISO9001:2015 standards
+ Effective communication, coordination, and administration skills with Internal/External Customers
+ Strong technical writing skills
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.
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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 ...@danaher.com to request accommodation.