JT320 - QUALITY ENGINEER II

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:  Perform and/or review process validation [PV: characterization, OQ, PQ] (not cleaning process) and equipment qualification [CSV: URS, FAT, IQ, OQ, PQ, TMV] (not laboratory).

Experience in production line.

Basic knowledge in defining validation strategies ( e.g.

requirements flow down from design to manufacturing ).

Experience with Risk Management documentation: pFMEAs.

Basic knowledge in statistics ( preferably using Minitab ).

Experience with projects: design requirements validation, manufacturing controls (not Operational Excellen...