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QA TECHNICIANDanaher Corporation • United States
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QA TECHNICIAN

Danaher Corporation
  • US
    United States
  • US
    United States
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About

QA Technician
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher's 15+ operating companies, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. 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. Take your next step to an altogether life-changing career. The QA Technician is responsible for assuring that all official documentation for Cytiva, Puerto Rico site, third parties and any additional applicable site are created, reviewed, and distributed to ensure accuracy, completeness and adherence to policies, procedures, and regulations. Responsible for the process and record retention of manual documents such as but not limited to batch records, validations, engineering studies, risk assessments. Responsible for creating and processing labels as submitted by the Engineer. Keeping documentation organized, safe and available. This may involve maintaining paper files, electronic files, or even databases. Update, organize and retrieve information from the Quality System. Provide information to customers and gather data for management. Information provided to management may include printed information, specific reports, and statistical data. Manage projects through the company Values, Core Behaviors and Danaher Business System (DBS) tools and processes. This position reports to the QA Compliance Manager and is part of the Quality Assurance Department located in Cytiva Fajardo and will be an on-site role. What you will do: Responsible to create certificates and labels and assures they are send in a timely manner to Cytiva's internal or external customers. Responsible for sending regulatory documents requests through system or email based on ISO, FDA and all applicable regulations and company procedures. Responsible to Assign Procedure, Validations, Engineering Studies and Risk Assessments Numbers. Who you are: Bachelor's degree in business administration, Science or related fields with two (2) to four (4) years of work-related significant clerical and/or secretarial functions in Documentation, manufacturing environment preferred. Ability to read and learn to interpret, apply, and explain rules, regulations, policies, and procedures and to complete work accurately and timely. General knowledge of GMP'S, QSR, ISO and FDA regulations and standards preferred and computer oriented, knowledge in Enterprise Resource Planning (ERP), Electronic Document Management (EDM), MS applications (Excel, Word, PowerPoint), SAP and Documentation (QA) System and Veeva System. It would be a plus if you also possess previous experience in: Regulatory Affairs knowledge and experience. Computer oriented, knowledge in Enterprise Resource Planning (ERP), Electronic Document Management (EDM), MS applications (Excel, Word, PowerPoint), SAP and Documentation (QA) System and Veeva System. Certified Quality Auditor or audit experience. Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. At Cytiva we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytiva can provide. The hourly range for this role is 17.00/hr. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. 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.
  • United States

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  • English
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