- Perform procurement and testing of: city and pharmaceutical grade water per USP guidelines and SOP; product for bioburden, endotoxin per USP guidelines and SOP; stability samples per SOP; environmental monitoring sample (viable and non-viable) per USP guidelines and SOP, as scheduled (daily, weekly, monthly, quarterly)
- Support production in qualification of clean rooms and water systems.
- Data entry for trending reports
- Perform QC testing and release of microbiological media, reagents, and stock cultures
- Maintenance of stock cultures
- Use of aseptic technique for sampling and testing of all samples collected for microbiological analysis
- Documentation of all activities per current good documentation practices as described in SOP
- Use basic understanding of and knowledge of techniques, instrumentation and lab functions to identify problems, initiate investigations and support completion of work assignments
- Maintain inventory and ordering of supplies, media, reagents and stock cultures used in routine testing
- Support test method development and qualification/validation studies
- Assist QC/QA group with writing and editing SOPs and Test Methods
- Must manage time well. Must be able to perform daily tasks in a timely manner – improving productivity while minimizing idle time.
- Follow approved cGMP directions such as standard operating procedures and other instructions in support of testing and production
- Provide backup and support for QC Micro Lab Technician
- Must be willing to work weekends as necessary.
- These responsibilities may change based on the business demand and the company’s organizational needs.