Microbiologist

QC Microbiologist

Primary Responsibilities:

• 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.

Qualifications:

• The successful candidate must be able to work on multiple projects with minimum supervision and meet established timelines.
• Qualified candidate should have BS in Microbiology or life sciences, 1-5 years of experience in Quality Control/cGMP environment; be familiar with USP, 21 CFR, and ICH guidelines in regards to cGMPs.
• Computer skills in MS Word, Excel and Access are desirable.
• Must possess strong interpersonal and communication skills (written and oral).
• Must be able to wear safety shores & glasses through-out the day while in designated areas. (provided by the company)
• You must be cleared by a physician to wear a respirator throughout the day while in designated areas.
• Must be able to work in a chemical environment.