||1. Five years of experience in a cGMP environment.
2. Three years of experience in solid oral dose manufacturing.
3. Must be able communicate in English both written and verbal.
4. Must be able to lift 40 + Lbs.
5. Must be able to stand and sit for long periods; squat, twist, kneel and bend occasionally.
6. Must be able to pass a company test with a minimum of 50%.
7. Skilled in basic computer use and software (i.e. Windows, MS Word, MS Excel, Navision).
8. Familiar with basic units of measure and unit conversion.
9. Familiar with basic algebra to perform calculations.
10. High School Diploma or equivalent (especially with courses in math, chemistry, physics).
11. Ability to learn through instruction and training.
12. Ability to be observant and have high attention to detail, even when performing repetitive tasks.
13. Desire for career and personal development and improvement.
Skills and/or Training Preferred But Not Required:
1. Bilingual (Spanish and English).
2. Solid oral dose development or manufacturing experience with understanding of critical product attributes and critical processing parameters for various manufacturing unit operations.
3. Tablet press setup and operation.
4. Familiar with common excipients in nutritional supplements, their functions and basic properties.
1. Fillers and Diluents
3. Disintegration agents
5. Technical writing skills to assist in process documentation and creating or revising standard operating procedures.
6. Familiarity with FDA guidance and regulations.
7. Familiar with common in-process testing techniques.
1. Tablet weight, thickness, hardness.
2. Tablet Friability.
3. Granulation density (bulk and tapped).
4. Particle Size testing.
5. Loss on Drying.
8. Experience with problem solving techniques and root cause analysis.