Position Details

The QC Analyst will be responsible for supporting utility qualification, utility testing, environmental monitoring, product testing and other tasks as required at the Phibro Animal Health Ltd. site.

KEY RESPONSIBILITIES
•    Understand and support testing of product samples including raw materials, intermediates and finished goods as well as environmental and clean utilities samples. 
•    Performance of laboratory tests as per standard operating procedures. 
•    Recording of analytical results accurately. 
•    Operations, maintenance and calibration of laboratory instruments. 
•    Generation or updates of necessary documentation to support the QC laboratory, i.e. procedures, work instructions and protocols. 
•    Execute microbiological/product method validations as needed for product and clean utilities qualification program. 
•    Performs bioburden and endotoxin sample analysis in accordance with standard operating procedures (SOPs). 
•    When required, performs virus neutralization and viral titration sample analysis in accordance with SOPs. 
•    Performs or supports the sample analysis for microbial identification. 
•    Conducts laboratory investigations and generates reports in response to invalid assays, deviations, OOS/OOT. 
•    Presents analytical data/trend reports clearly and concisely to management. 
•    Sampling and testing to support qualification and re-validation of utilities and cleanrooms. 
•    Ensures cGMP & GLP standards are maintained and adherence to scheduled to meet regulatory and business requirements. 
•    Support the execution of pilot scale vaccine manufacturing processes for proof-of-concept and optimization trials. 
•    Other duties as required. 

KEY COMPETENCIES, REQUIREMENTS, COMPLEXITY
•    Knowledge of microbiology, chemical and physical test methods. 
•    Excellent attention to detail and significant data review experience essential. 
•    Effective time management and multi-tasking skills. 
•    Demonstrate ability to drive the completion of tasks, trouble shooting skills and excellent attention to detail. 
•    Excellent technical writing skills including investigation reports, deviation reports and validation reports. 
•    Adaptable and flexible to meet the companies requirements. 

EDUCATION, KNOWLEDGE, YEAR OF EXPERIENCE
•    A minimum of an Honours Bachelor’s degree in a technical discipline (e.g. biochemistry, chemistry, biotechnology, biopharmaceutical science). A Bachelor’s degree in Science with additional significant microbiology lab experience will be considered. 
•    A minimum of 3 years of industry experience within a GMP laboratory. Significant microbiological skills and understanding will be considered an advantage. 
•    Experience with vaccines would be preferable particularly in the area of viral titrations, ELISA and PCR testing. 
•    Must have experience in authoring, review and execution of method validations studies and reports. 
•    Experience in laboratory investigations, deviations and change controls will be considered an advantage. 
•    Experience gowning and entering cleanroom areas.