Microbiology Analyst I

Description

The QC Microbiology Analyst I performs microbiology department related raw material, in-process, and finished product testing according to USP methods and established procedures that follow cGMP guidelines and demonstrate outstanding aseptic techniques. Must demonstrate a high level of proficiency in Microbiology testing.  

· Applies quality scientific techniques in the microbiological analysis of raw materials; in-process & finished product samples to include: sterility, bioburden, identification, environmental monitoring, growth promotion, microbial recovery and media fill tests following approved procedures. 

· Notifies Microbiology management of all OOS and OAL testing results. 

· Provides feedback on SOPs, forms, logbooks, etc., as necessary, to facility ever-changing expectations for operating procedures and testing-related information.  

· Performs routine testing of products to support release and company needs.

· Trains fellow QC laboratory personnel on QC test methods. 

· Demonstrates ability to understand and interpret test results in relation to acceptance or rejection of lot tested.

· Generates data, as needed, for investigations; performs data entry for various systems and processes, and understands the necessity of trending reports 

· Reports and initiates documentation and communication of OOS and OOT results and investigation reports.

· Assists the Sample Management team with sample receiving and waste destruction, as needed.

· Performs method validation testing if requested by supervisor.

· Performs general laboratory housekeeping and upkeep of various testing stations.

· Communicates all Microbiology-related observations, issues, problems, discrepancies, and any violation of company policies or procedures to QC Microbiology Shift Lead, QC Microbiology Supervisor, QC Microbiology Operations Manager, Director of Microbiology, or designee.  

• Performs other duties as assigned.

• This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.

· Hours of work: 12-hour rotating shifts.  

· Salary range: Based on experience. 

• 2 – 4 years of experience with Microsoft Office programs, as well as the ability to learn new systems and computer software programs effectively and efficiently required.  
• Experience with cGMP documentation systems and with implementation of quality control systems.  
• Strong interpersonal, verbal, and written communication skills; effectively multi-tasking and problem solving skills.   
• Must maintain flexibility in the assignments of tasks, and be open to receive and provide training in multiple areas.   
• Knowledge of FDA manufacturing/regulatory quality systems regulations, qualifications, facilities, and requirements.  
• Accepting of new changes in order to achieve department demands.  
• Must possess effective written and oral communication skills and be able to handle multiple tasks within limited time frames. 
• Aseptic technique and familiarity with cGMPs and regulatory requirements is required. 
• Specific expertise, skills and knowledge within microbiology gained through education and experience. 
• A broad perspective that aligns decisions to organizational objectives and long term consequences of day-to-day activities. 
• The ability to take strategic objectives and accept accountability to drive results through effective actions. 
• The ability and willingness to change direction and focus to meet shifting organizational and business demands. 
• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve      development goals. 
• Position requires bending, typing, lifting, reaching, vision, standing (50%), sitting (10%), walking (20%), and hearing. 
• Incumbents required to wear safety glasses, gloves, laboratory coats and other non-specified protective equipment as      necessary. 

• Regionally accredited Bachelor’s Degree in Biology, Microbiology, or Life Sciences, required; Master’s degree, preferred.  

· At least 1-year experience working directly with Pharmaceutical Microbiology methods.  

· 1 – 2 years of experience in general laboratory skills and a knowledge of aseptic technique.