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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:

+ 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.

+ Performs system administration and configuration of quality information technology systems.

+ Performs investigation non-conformance events

+ Initiates, recommends, and provides solutions to the Non-Conforming Product as per procedures.

+ Verifies the implementation and effectiveness of non-conforming CAPA.

+ Executes job responsibilities as established in the procedures.

+ Follows the documentation procedures Non- Conformance Resolution.

+ Evaluating, Investigating & Completion of Non- Conformance.

+ Investigation (Data gathering of Quality issue).

+ Identify an implement Corrective/Preventive Actions.

+ Lead complaint activities with the Operating Units members.

Qualifications:

+ Bachelor’s degree in Engineering

+ Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

+ Lean Six Sigma Green Belt Certification

+ Experience using Microsoft Office (Excel, Word, Outlook, Power Point, Project), Agile, HR - ABRA Suite, Maximo, MRO Program, SAP, TEDS, Compliance Wire, Gallup On-line Tool.

+ Knowledge of Good Manufacturing Practices

+ Good oral and written communication skills (English and Spanish)

+ Computer knowledge (Excel, Word, Power Point, etc.)

+ Good problem-solving skills

+ Ideal candidate must be fully bilingual

+ Able to set effective priorities and implement decisions to achieve immediate goals.

+ Administrative Shift

+ Availability to work overtime and weekends when necessary.

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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