Instrumental chemical and physical analysis of laboratory samples to determine its conformance with established specifications. Standardization of solutions and calibrations, qualification and validation of sophisticated instruments and methods, responsible for the safe execution of the assigned testing procedures and proper documentation according to the applicable QS, procedures and/or company policies. Knowledgeable of Regulated Laboratory Environment and cGMPs, FDA and DEA guidance.
EDUCATION AND/OR EXPERIENCE
• Bachelor’s degree in science with a Chemistry or Biology majors.
• At least one (5) year of laboratory experience; preferred
LICENSES AND/OR CERTIFICATIONS
• A license to manage explosive material, preferred
• Chemist Licensed is preferred.
• Good oral and written communications skills in English and Spanish (Bilingual).
• Excellent interpersonal skills.
• Knowledge in computers and domain the use of standard computer software applications.
• Understands GMP’s, FDA and DEA regulations, Computer Validation philosophy and method transfer/ validation.
• Knowledge of Good Manufacturing Practice regulations, GLP, EPA regulations, Laboratory Safety Rules, OSHA regulations, classical and modern analytical chemistry or microbiology and sophisticated instrumental techniques.
• Knowledge on HPLC, GC and Dissolution as well as their acquisition system as Empower 3.
• Able to Work under pressure, self -starter and able to handle multiple priorities with minimum supervision.