I. JOB SUMMARY –Responsible for performing visual inspection of sterile filled containers (vials) in accordance with all applicable procedures, regulations and safety directives.
II. JOB DUTIES – ·
1. Repetitive handling of sterile filled containers while seated, shaking containers and extending arm out in front of light source in order to identify defects.·
2. Records production quantities and other appropriate information.·
3. Applies moderate level of math skills to included piece counting.
4. Follows written procedures and document results in a neat and accurate manner according to GMP standards and other regulations.·
5. Performs daily cleaning of packaging work area in accordance with established procedures.·
6. Identifies and communicates quality issues.·
7. Maintains attention to detail and quality while completing multiple or repetitive tasks, and meeting timelines and deadlines.·
8. Effectively communicates both verbally and in writing with all levels.·
9. Maintains a high level of integrity while balancing all responsibilities.·
10. Performs all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.
III. PREPARATION, TRAINING & EXPERIENCE – PERSONAL SKILLS & COMPETENCIES·
1. Ability to read, understand, follow and comply with technical and written documents (SOPs) written in English.·
2. High school diploma or equivalent required.·
3. Must be able to maintain visual qualifications: (20/20 vision corrected or uncorrected checked annually); ability to see all colors and the ability to visually discern product specifications across multiple products. ·
4. Some basic computer skills required.·
5. Must be able to work while wearing PPE for all GMP areas for an entire shift. (Includes non-latex gloves, hair\beard covers and lab coats).·
6. Previous employment within and FDA/USDA, GMP environment is highly desirable