QA TECHNICIAN

• Bring more to life.

  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.

  Learn about the Danaher Business System which makes everything possible.

  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: (NOTE For Hiring Manager: (NOTE For Hiring Manager: Please reference the 3-5-7 Job Requirements Model)

• 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.

• Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role

• N/A

• 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. Check out our benefits at Danaher Benefits Info.

  Insert Job Posting Language, if applicable:

  Good oral and written communication skills (English and Spanish)

  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.

  Insert Pay transparency language for locations where it may be required by law, if applicable:

  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.

  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.

Bilingual (English and Spanish)

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.

The U.S. EEO posters are available here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or applyassistance@danaher.com.