Job Description

- Performs environmental monitoring sample collection, testing and result reporting supporting aseptic filling including work during non-routine business hours - Performs Utility Monitoring sample collection and reporting including bio-burden and endotoxin testing on controlled water/clean steam systems and particulate sampling for compressed gases - Microbial Identification - Aseptic sampling of raw materials and stability samples - General laboratory functions such as inventory, control and ordering of laboratory supplies, equipment preventive maintenance, general laboratory housekeeping, and chemical and biohazard waste disposal - Good documentation practices associated with the generation of raw data, data entry and reporting - Revision of SOP’s as required - Performs and documents required training to perform job function

Requirements

- Good verbal, written and interpersonal communication skills - Knowledge of cGMP - Must be able to follow written SOP’s / work instructions - Trainable in standard safe chemical handling techniques - Ability to work with hazardous chemicals - Ability to operate and perform analysis on product using basic microbiological techniques and instrumentation - Good organization and recordkeeping skills - Good computer skills

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