Quality Systems Specialist

Seeking highly motivated and determined Quality Systems Specialist!! Must work cross functionally owning and managing action items such as Trackwise, Deviations, Change Controls and CAPAs! The candidate will manage documentation review and revision process under general supervision. Must be able to exercise judgment, conduct investigations determine product impact, identify root cause, and identify corrective and preventative actions!


-Provide expertise on Supply Chain process to support deviations with other departments

-Demonstrate capability to analyze and solve low-mid level process related issues

-Investigate and document data assessment for minor and major deviations

-Investigate, contribute, and revise standard operation procedures

-Actively participates cross functional teams internally and externally

Education Requirements

-Bachelors in science, Engineering or related

-Minimum 2 years' experience with Quality Assurance, Quality Control, and development of biologics or pharmaceuticals

-Provides clear, concise, written and verbal communications within a timely manager

-High level of professionalism, judgement, and problem solving independently or under guidance of senior managers/ members

-Proficient in TrackWise or equivalent, Visio, Project and SharePoint

-LIMS, SAP, Applications a plus

If you are interested in this Quality Systems position, then please send a copy of your resume to the attention of Matthew Wong and his team at Real Staffing.

Sthree US is acting as an Employment Business in relation to this vacancy.