Assist in the preparation of media, maintenance of dehydrated and prepared media stocks, and sterilization of media accessories by autoclave cycles.
Assist in the maintenance of Master cultures Isolates and preparation of Cryo vials.
Manage receipt, storage, and handling of Bio ball cultures.
Perform water analysis, Microbial Limit Test, Sterility tests, Bacterial Endotoxin Test and Assays, CCIT, and micro challenge studies.
Ensure training records are updated and correctly filed to reflect current testing capabilities.
Perform sampling and labeling of materials as per defined procedure and verification of all the equipment/instruments.
Interpret and evaluate data in terms of accuracy, precision, trends, and potential Good Manufacturing Practices {also cGMP} impact and recommend appropriate corrective actions.
Ensure all documentation and quality records are conducted in accordance with Good Manufacturing Practices and Good Laboratory Practices requirements and that they are filed in accordance with existing policies.
Review and revise Standard Operating Procedures (SOPs), analytical methods, and related procedures/documents, to keep them current.
Perform analyses on finished products, raw materials, and components including entry, review, and/or approval of data in a computerized database and generate EMS reports.
Conduct Microbiological protocols on an as-needed basis.
Contribute to the completion of complex projects, manage own time to meet agreed targets, and develop plans for work activities on own projects within a team.
Qualifications
Must-Have
Bachelor’s Degree
Demonstrated technical skills in method validation and testing
Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations
Knowledge of Good Manufacturing Practices and their application standards, processes, and policies
Excellent organizational skills and strong ability to multi-task
Strong written and verbal communication skills
Nice-to-Have
Laboratory work experience with analytical HPLC (High-Pressure Liquid Chromatography) technique
Experience leading continuous improvement projects
Knowledge of lean manufacturing, six sigma methodologies, and statistics
