Nature & Scope:
The Quality Control Microbiologist prepares and tests samples from all phases of a manufacturing or other handling process, with the goal of determining if the substance meets the microbial limits or requirements of the project. They perform a variety of microbial methods that can vary but generally require basic microbiological and laboratory skills and a general understanding of microbial identification. The scope of responsibility for this position crosses multiple departments, therefore the incumbent shall collaborate with various departments. They have a role in preserving workplace safety and safe materials handling as appropriate, since they sometimes work with hazardous materials.
The responsibilities of the QC Microbiologist include, but are not limited to the following:
• Testing and release of finished products, stability samples, raw materials, registration, clinical and marketed products batches under GMP/GLP environment as per company's standard operating procedures and USP/FDA guidelines.
• Prepare reagents, samples, and standards according to procedures.
• Maintain up to date documentation. Enter all raw data directly into the notebook and promptly calculate all test results.
• Document testing, observations, deviations, OOS investigation and results clearly and completely.
• Schedule, request and execute the QC inspection tests and/or experiments.
• Peer review notebooks and test results generated by other QC team members.
• Critically evaluate and interpret experimental data. Immediately inform supervisor of issues and assist in the resolution of complex problems.
• Maintain laboratory equipment and instrumentation in good working order, following appropriate procedures for usage, clean-up and maintenance.
• Maintain and follow all laboratory systems, GMPs, safety and housekeeping requirements.
• Teach, train, coach, and advise other QC team members on microbiological techniques and methods.
• Prepare and review SOPs, as required.
• Perform Quality Inspection functions, assist with water sampling and monitoring.
• Support sampling and testing for cleaning validation, process validation and method validation as required.
• Maintain familiarity with current scientific literature and technologies.
Education & Experience:
• Minimum - Bachelor of Science in Microbiology, Biology or equivalent
• Strong attention to detail in order to produce accurate, precise, and reproducible data
• Strong analytical, organizational, and time management skills
• Task oriented and results driven
• Strong work ethic and prioritization skills
• Work collaboratively with various departments to compile, analyze, and interpret data
• Manual dexterity
• Ability to follow written protocols
• Ability to work in a fast-paced environment
• Excellent written and oral communication skills - ability to make presentations and/or give presentations
• Must be able to lift 25 lbs
• Must possess a valid US Driver's License