Environmental Monitoring Analyst - Microbiology

Duration: 07 Months+

• Perform Quality Control Microbiological testing of Environmental Monitoring (EM) - for viable air, non-viable particulates, surface viable monitoring in manufacturing areas,cleanrooms.
• Perform testing for gram staining,microbial identification, Media growth promotion, endotoxin testing, plate reading, and documentation.
• Support cleanroom qualification, gowning qualification, aseptic process qualification and personnel monitoring for manufacturing activities.
• Receive samples for analysis, ship samples for contract lab testing, enter,review data, and organize data according to cGDP,GMP requirements.
• Revise SOPs,forms, and Initiate incident reports for OOS results -support root cause analysis for EM excursions.
• Assist in EM data review for trending and other technical documentation or projects.
• Perform lab set up, housekeeping,routine cleaning, schedule equipment for preventative maintenance, and organization of laboratory areas in accordance with cGLP,GMP.

Required:

• Bachelor’s degree in biology, microbiology or related life science with 1-2 years’ relevant GMP,pharma,microbiology laboratory experience
• Ability,Flexibility to work evenings and weekends,holidays is required- to support manufacturing operations
• Good knowledge of Aseptic technique and common microbiological testing
• Knowledge of relevant, compliance and guidance documents, documentation (ALCOA +) and data organization
• Must be able to gown into cleanrooms in support of testing and manufacturing activities
• Detail oriented, willingness to learn and follow instructions
• Interpersonal skills and ability to contribute to the success of a team