Quality Control Microbiologist

Job Summary

Required Qualifications

• •Sound knowledge of quality control systems, methods, and procedures
• •Conducting microbiological analyses for raw materials, intermediates, and finished product samples according to written procedures
• •Developing and writing methods for analysis of all raw materials, intermediates, and finished product samples
• •Accountable for analytical testing of raw materials, intermediates, and/or finished product samples as required by the procedure
• •Reviews data and results of testing to ensure compliance to appropriate specifications and protocols
• •Writes and executes protocols for the qualification and re-qualification of new and current instrumentation
• •Troubleshoots instrumentation/test methods
• •Updating specifications and other appropriate databases
• •Establish and validate test methods via internal testing and/or 3rd party approved analytical labs
• •Maintain a library of pertinent published reference material including monographs, books, studies, and compendia
• •Ensuring analytical methods are updated and documented
• •Follows technology changes, recommends new technologies, purchase and implement if appropriate
• •Assisting investigating non-conforming products and disposition
• •Assist with investigations and pertinent customer complaints and submit findings to QC/QA manager
• •Staying abreast of regulatory changes related to the industry
• •Assisting as needed in all other aspects of the QC department
• •Knowledge of systems such as HPLC, HPTLC, UV-Vis, ICP-MS, and FT-IR
• •Understanding of Pharmacopoeial requirements and must be able to follow changes, implement changes, qualify methods
• •Understanding of USP/EP/CMSP and other pharmacopoeias as well as the change process
• •Working knowledge of GMPs, GLPs, phamacopoeial, and regulatory requirements for testing and validation pertaining to the dietary/herbal supplement industry
• •Investigation skills
• •Report writing skills
• •Ability to work quickly and accurately in a production environment
• •Good verbal, written, and interpersonal communication skills
• •Proficiency in Microsoft Office applications
• •4+ years of relevant experience and a BS degree in Chemistry or equivalent
• •2+ years of relevant experience and a MS
• •Prior experience in a manufacturing industry
• •Able to sit for long periods of time
• •Some walking, standing and sitting
• •Some lifting of at least 50 pounds on occasion

Desired Qualifications

• •Prior experience in a manufacturing industry is preferred