QA Technician

Danaher • Fajardo, PR

4d • $17 • Onsite

About The Position

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.

Requirements

• 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.
• Good oral and written communication skills (English and Spanish)

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 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 .
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees