Under the direction of the Manager, the Microbiologist is responsible for USP microbial evaluation testing, environmental monitoring & media preparation. Also, responsible for adhering to the Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMPs) that are in effect assuring the quality and quantity of product produced.
- Performs routine testing of samples - procedures maybe readily available through Compendia methods or in-house method references
- Processes samples for chemical and /or biological analyses. This may involve collecting specialized samples in various production areas
- Reports results of assignments and maintains and performs related record keeping in compliance with approved regulatory policies and standards to meet quality and accuracy requirements
- Complies with company policies and procedures and maintains regular work attendance
- Performs other duties as assigned
Knowledge of USP and or FDA microbiological test methods. Experience within a microbiology lab supporting manufacturing operations preferred.
0-3 years experience.
Education - Certification - Licenses & Registrations:
BS Degree in biological sciences, microbiology, med tech or related.
Aseptic technique, Maintenance of microbial stocks, gram stain and identification techniques, environmental monitoring
Frequent standing, some lifting, hands- repetitive motion processing samples, Collection of samples from various production areas.
NBTY - 12 months ago