|Job Description: |
Coordinates analytical laboratory testing. Performs analytical testing. Conducts and documents OOS investigations. Drafts new procedures and/or changes to SOP’s to keep current or improve cGMP status. Ensures conformance of all laboratory activities to appropriate cGMPs. Enforces compliance to regulatory, safety procedures and the Chemical Hygiene Plan. Develops, recommends, and implements systems, processes, activities, SOPs to improve quality of analytical results. Ensures that lab documents and lab data (paper and electronic) are properly classified, controlled, and stored. Performs analysis of samples as required. Provides training of analytical personnel on each new method and new equipment. Ensures that all lab instruments are functional and suitable through coordinating preventive maintenance, troubleshooting, appropriate calibration, instrument upgrades, etc. Acts as liaison to vendors and outside laboratories regarding instrumental analysis/methods.