QUALITY ENGINEER II

SUMMARY OF POSITION: Develop, implement, coordinate and supervise resources in the execution of validation projects including equipment, packaging and process validations to comply with FDA, cGMP, and any other appropriate regulations. Support manufacturing and packaging with new product introductions, process improvements and provide technical support as required.
ESSENTIAL FUNCTIONS/SKILLS:
1. Manage multiple projects through validation, transfer and/or exhibit studies.
2. Protocol and report generation in support of the above studies.
3. Coordinate activities in support of the Validation Department priorities with the assistance of the department manager.
4. Perform in process sampling as defined in study protocols.
5. Interface regularly with other departments, assist and direct personnel who are not direct reports in defined projects.
6. Prepare and maintain validation records in accordance with validation studies


Requirements:

Education required/ preferred: Four-year technical BS degree in a related field.
1-3 years of technical pharmaceutical experience (includes QA or engineering experience).
Experience: This job requires strong written and verbal communication, strong mathematical aptitude and strong computer literacy in MS Office products.




To apply online, please use the following link: