Cytiva
Senior Document and Training Specialist
Cytiva, Marlborough, Massachusetts, us, 01752
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 at 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 anticipate 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 a minimum of 8 years' experience in a regulated industry
Bachelor's degree in applicable field or equivalent 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 a comprehensive package of benefits including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.
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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 at 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 anticipate 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 a minimum of 8 years' experience in a regulated industry
Bachelor's degree in applicable field or equivalent 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 a comprehensive package of benefits including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.
#J-18808-Ljbffr