Quality Consulting Group, LLC
JT359 - ASSOCIATE QUALITY APPLICATIONS SPEC
Quality Consulting Group, LLC, Juncos, Juncos, us, 00777
QUALITY CONSULTING GROUP, a leader inthe 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
Conducts a compliant validation process for quality information technology systems
which requires formal validation documentation ( including standard operating procedures ) under appropriate federal regulations.
Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global.
Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance
according to the appropriate federal and international regulations which govern the user's applications. Reports on the status of validation activities to fulfill regulatory requirements.
Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
Performs system administration and configuration of quality information technology systems.
Qualifications
Bachelor’s degree required in
Science or Engineering.
0-3 years of medical / clinical experience or exposure
Must be
Bilingual (English and Spanish)
Knowledge in
Six Sigma, CAPA and Product Nonconformance.
Knowledge in the following systems: SAP QM Module
Trackwise Systems
Agile system and FactoryWorks system
Knowledge in regulated industries.
Working Shift: 1st shift
Equal Opportunity Employment 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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Responsibilities
Conducts a compliant validation process for quality information technology systems
which requires formal validation documentation ( including standard operating procedures ) under appropriate federal regulations.
Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global.
Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance
according to the appropriate federal and international regulations which govern the user's applications. Reports on the status of validation activities to fulfill regulatory requirements.
Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
Performs system administration and configuration of quality information technology systems.
Qualifications
Bachelor’s degree required in
Science or Engineering.
0-3 years of medical / clinical experience or exposure
Must be
Bilingual (English and Spanish)
Knowledge in
Six Sigma, CAPA and Product Nonconformance.
Knowledge in the following systems: SAP QM Module
Trackwise Systems
Agile system and FactoryWorks system
Knowledge in regulated industries.
Working Shift: 1st shift
Equal Opportunity Employment 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.
#J-18808-Ljbffr