QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

　　Responsibilities:   

　　Evaluate impact of validated computer impact with existing work instructions. 

　　Responsible for prepare computer validation. 

　　 Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.

　　Complies with company programs, procedures and applicable quality system regulations and standards.

　　Leverages technical expertise and knowledge of client standard engineering approaches, design concepts and specification requirements to best utilize equipment and manufacturing techniques.

　　Generate installation qualification documents. 

　　Execute qualification protocols and generate qualification report. 

　　Organize and maintain project status progress detail.  

　　Work with process owners to process changes to existing work instructions.

　　Qualifications: 

　　Bachelor Degree in Engineering

　　Three (3) or more years of experience 

　　Investigation and root cause analysis skills,

　　Technical writing knowledge,

　　Process Validation and Computerized Systems Validation

　　Experience in FDA regulated industries

　　Experience configuring and troubleshooting Windows 10 desktops

　　Excellent verbal and written communication skills (English and Spanish).

　　Available to work in any shift. 

　　Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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