Biochemistry Analyst II - CARsgen Therapeutics Corpora
Durham, NC
About the Job
- Responsibilities
- Conduct microbiological assays such as growth promotion of media, finished product sterility testing, and endotoxin testing of products and raw materials.
- Environmental monitoring of room air and surfaces in classified areas using laser particle counters and biological air samplers.
- Environmental monitoring of compressed gases for viable and nonviable particles, oil and moisture.
- Prepare and maintain microbial cultures and stock solutions.
- Participate in validation and qualification studies for microbiological methods, classified areas and clean utilities.
- Initiate deviations and laboratory investigation and participate in investigations as needed.
- Participate in laboratory operations including equipment maintenance, laboratory reagent and inventory management.
- Review assay results, environmental monitoring data and logbook entries.
- Make minor revisions to SOPs and forms.
- Identify and communicate risks to upper management.
- Qualifications
- Bachelor of Science degree in microbiology, biochemistry or a related life science.
- Experience in GMP quality control, quality assurance or manufacturing preferred.
- Aseptic processing, environmental monitoring, pharmaceutical manufacturing, or pharmaceutical microbiology backgrounds are preferred.
- Understanding of applicable USP, ICH, and Ph Eur standards is preferred.
- Excellent verbal and written communication skills.
- Some experience troubleshooting analytical equipment and methods preferred.
- Ability and desire to work in a fast-paced, team-oriented environment.
Source : CARsgen Therapeutics Corpora
