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 Specialist for Cytiva is responsible to :
Develop and promote a 'quality culture' that is embraced by personnel within the organization,C arry out QA/QC functions to ensure accurate and timely completion of tasks and documentation, and Carry out or participate in projects to ensure continuous improvement in the QA/QC department. This full-time position is part of the Quality Assurance department located at the Tauranga site in New Zealand and will be based on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
In this role, you will have the opportunity to: Attend and complete all applicable training within the defined deadlines and raise any quality concerns with the manager.Maintain and develop the Quality System to meet cGMP standards.Lead Complaint Handling, Investigative Processes, Corrective & Preventative Actions, Planned Deviations, Change Control and Continuous Improvements.Provide back-up services to the QC Laboratory.Review and Approve Product Labels.Lead internal audits and Quality Gemba walks.Review QA/QC Logbooks and Batch Records.Coordinate QC testing of manufactured product.Review calibration certificates.Manage the Veeva QMS & Document Management system, and Cytiva Learning system.Lead preparation for customer & regulatory audits and visits.Review QA/QC documents.Undertake QA/QC projects as required.Any other tasks that may be reasonably requested. Quality & EHS The employee is trained in the Quality Policy.Each employee is responsible for the quality of all products and services and compliance to the Quality Policy.Execute on time all quality actions within compliance records.The employee is familiar with the safety policy and the site EHS objectives.Respect the rules and procedures to protect employees' health and safety and to preserve the environment.Attend the applicable safety training and execute the tasks identified under his responsibility.Raise a concern if a dangerous situation occurs.Execute on time actions under his responsibility to continuously improve work conditions and environment protection.The essential requirements of the job include: Knowledge of quality systems (ISO 13485, ISO9001) and associated documentation.Knowledge of medical device industry and medical device regulations.Bachelor's degree or equivalent in a related field.At least 2-3 years' experience working in a regulated environment.Very proficient in attention to detail, statistical analysis and problem solving.Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.Ability to remain calm and receptive in fast paced situations. Be able to plan and organize and manage own workload and changing priorities at short notice as required.This job is eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off and medical insurance.
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When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
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.
If you've ever wondered what's within you, there's no better time to find out.
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.
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