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.

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.

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

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 equivalent2+ years of relevant experience and a MSPrior 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
#J-18808-Ljbffr