QA TECHNICIAN
About The Position
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.
- Bilingual (English and Spanish)
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
- comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
