Job Opportunity for Clinical Trial Associate
This is an exciting role that involves providing technical support for new product introduction and commercial manufacturing.
The successful candidate will be responsible for contributing to cross-functional teams, collaborating with vendors and site groups to drive process improvements, and executing qualification/validation documentation and process development studies.
* Key responsibilities include designing, authoring, reviewing, approving, and executing qualification/validation documentation and process development studies;
* contributing to Kaizen events and providing technical input into quality notifications;
* executing equipment/qualification validation programs, including re-qualification and re-validation;
* supporting continuous improvement through Lean Six Sigma methodologies;
* performing root cause analysis of system failures and substandard performance.
Applicants should have a Bachelor's Degree or higher in a Science, Engineering, or Technical discipline. A minimum of 3 years of experience in manufacturing, preferably in a GMP setting, is also required. Demonstrable experience of leading technical-related projects and evidence of continuous professional development are highly desirable.
Requirements:
* Knowledge of process monitoring systems, automation systems, and operational intelligence & data systems within a GMP manufacturing environment;
* proficiency in Microsoft Office and job-related computer applications;
* excellent communication, presentation, and interpersonal skills.
Candidates who are motivated, detail-oriented individuals with a passion for process improvement are encouraged to apply.