Quality Control Microbiologist

This is a more experienced position requiring sound knowledge of quality control systems, methods, and procedures. The QC Microbiologist will be responsible for conducting microbiological analyses for raw materials, intermediates, and finished product samples according to written procedures.

1. Duties and Responsibilities include but are not limited to:
   • • • Developing and writing methods for analysis of all raw materials, intermediates, and finished product samples as required
       • 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.
       • Other duties as assigned by the QA/QC manager.

1. Knowledge, Skills, and Abilities:
   • • • 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 is required.
       • 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

1. Performance Measurements:
   • Attendance and promptness
   • Meeting quotas and goals
   • Following appropriate SOP's and department procedures
   • Making recommendations and continuous improvements
   • Dependability & Accountability

Education & Experience:

• 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 is preferred

Physical

• Able to sit for long periods of time
• Position will require some walking, standing and sitting

Some lifting of at least 50 pounds on occasion may be required