Quality Assurance Specialist ll
Expiry Date :
Mon, 26 Apr 2021 23:59:59 GMT
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Be part of something altogether life-changing Working at Cytiva in the Life Sciences industry 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. Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives. What you ll do * Responsible for ensuing compliance in accordance with documented procedures for all aspects of operations as well as functional responsibility. * Review validation documents for adherence to Good Documentation Practices and compliance with procedural requirements. * Ability to understand and assess technical specifications for changes and their impact to change control requirements. * Approve specifications in the document management system. * Review and approve change control records to ensure risk assessments are appropriate, actions reflect change impact assessments, and records adhere to procedures. * Assist end users with change records in Veeva QMS system. * Support new projects that impact the QA department and job responsibilities. * Performs a broad variety of tasks in support of quality and production as assigned by the departmental manager. * Participate in Change Control Board meetings. Who you are * Bachelor’s degree from an accredited institution (Experience may be considered in lieu of a degree in unique circumstances). * Demonstrated understanding or aptitude to understand regulatory requirements including FDA CFR 21 820 and ISO 13485. * Demonstrated proficiency in word processing, spreadsheet, and presentation software. * Strong interpersonal communication skills with the ability to effectively communicate and work interdepartmentally. * Ability to accomplish goals and work with minimal supervision. * Demonstrated understanding or aptitude to understand continuous quality/process improvement tools (risk assessments, 5S, SPC, DMIAC, root cause analysis tools). * Maintains a positive attitude, is self-motivated, and works well independently and as part of a team. * Attention to detail * 0-1 years of relevant work experience. * Quality Assurance experience in a regulated industry preferred. When you join us, you ll also be joining Danaher s global organization, where 68,000 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. Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we ll empower you to push the boundaries of what s possible. If you ve ever wondered what s within you, there s no better time to find out. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.