Quality Associate I, Baxter

Quality Associate I

Baxter

Location:

United States of America, Aibonito

Category:

Quality Control

Contract Type:

Not provided

Salary:

Not provided

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Job Description:

Incumbent will be responsible for insuring compliance with the Quality System Regulation regarding Quality and Manufacturing Processes and methods. Must be knowledgeable of all processes, product specifications and quality functions. Provide support and service to their respective areas. Responsible to ensure their responsibility areas are in compliance with internal and external regulations.

Job Responsibility:

Participates in the revision of Process and Software Validations protocols of equipment, new product and/or database applications
Participate and maintain full knowledge of the operations
Prepare on a Monthly basis the Quality Data Review and Management review presentations of the Operations area
Responsible of the Day to Day Quality Operations activities of the operations area
Product Retention Records approval and closing
Create and modify procedures as needed
Attend meetings where day to day activities are discussed such as Tier
Support POMS System
Approval of exceptions and comments as Quality Representative
Take decision, problem solving, time management, negotiations, personnel interview, feedback and recognition
Support in the implementation of Corrective and Preventive Actions
Evaluation and approval Non-Conformance Records and Corrective and Preventive Actions
Evaluation and Approval of Change Control records
Be facilitator of long term Quality Improvement Programs
Keep in compliance with GMP, FDA, ISO requirements, and other Regulatory Agencies
Support the design, development, enhancement of new product, processes and technologies
Active Participation in the Non Conformances investigation process
Any special project as assigned
Promote a zero-harm work place and assure that required EHS resources are available and that all applicable EHS practices and rules are being followed by supervised employees

Requirements:

Bachelors Degree in Science
Zero to One-year experience
Fully bilingual (English & Spanish)
Uses management practices/knowledge, statistical methods, computer systems and technical reporting
A self-starter capable of maintaining full understanding and up to the moment information of the Quality day-to-day activities
Excels in communication with individuals at all levels
Skilled at supervising tasks efficiently and on time
Must be willing to travel occasionally

What we offer:

Vacation and Paid Holidays
Medical, Dental, Disability and Life Insurance coverage
Vision and Voluntary Benefits
Paid Parental Leave
Retirement Savings Plan – 165E
Employee Stock Purchase Program
Educational Assistance Plan

Additional Information:

Job Posted:

March 20, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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