Microbiologist

Position Summary

Testing pharmaceuticals, vitamins and herbal products for microbiological content/contamination according to USP, AOAC, FCC, BP (British Pharmacopeia) and internal procedures. Occasionally assists in other laboratory tests and operations. Properly disposes of biological and chemical waste based on OSHA requirements.

Handles approximately 15 - 35 analytical tests per week

• Works with lab instruments, e.g. pH meter, microbiological testing equipment, analytical balances, micropipettes, etc. Also works with chemicals and reagent solvents during the day.
• Must use sterile technique and maintain sterile environment when performing microbiological related tests/activities.
• Reports any lab instrument malfunctions to Lab Manager.
• Prepares and files all Quality Control documents, e.g. Certificate of Analysis (COA) Deviations, Out of Specification (OOS) reports.
• Reviews tests and notebooks to ensure correct product analysis is performed.
• Conducts daily calibration of balances and pH meter.
• Appropriately disposes of biological and chemical waste.
• Proper disposal of expired raw materials, in-process and finished goods (final batches). Coordinates such activities with Safety Manager.
• Prepares samples for shipment to outside testing laboratory.
• Maintains the inventory of supplies and upkeep of laboratory and laboratory machinery.
• Preparation of purchase orders, receipt of supplies, and interfacing with other departments to expedite these functions.
• Maintains records of tested products and results.
• Notifies manager of out of specification result without delay.
• Maintains laboratory notebooks, equipment logs, and ensures equipment used is properly maintained and not past its next required calibration (if it requires so).
• Prepares specifications for raw materials and finished products.
• Supports the preparation, manufacture, evaluation and documentation of new or modified R&D in-process and finished products associated with Country Life formulations, e.g., tablets, capsules and powders.
• Writes detailed scientific instructions and lab procedures.
• Develops analytical methods and validations.
• Performs analytical troubleshooting and updates SOPs, log books and lab solutions preparation book.

• Must wear Personal Protective Equipment (PPE) at all times as stipulated by SOPs. e.g. respirator, ear plugs, hair net, beard cover and lab coat.
• Lifting up to 20 lbs. may be required. Position requires considerable standing on lab floor.
• Maintains professional and technical knowledge by attending educational symposia; reviewing professional publications; establishing personal networks; participating in professional societies, etc.
• Satisfactory completion of appropriate corporate training as related to the position and/or department.
• Assures compliance by following Food and Drug Administration's Good Manufacturing Practices (FDA cGMPs / GLPs) as well as other regulatory standards as required by the department.
• Contributes to overall achievement by accomplishing related tasks and demonstrating characteristics that exemplify team building and support.
• The above is not intended to be an all-inclusive list of responsibilities. Other activities may be assigned as required by management.

• One year Pharmaceutical laboratory or related experience as well as good mechanical aptitude. Training on specific laboratory equipment and instruments is preferred and may be provided if no work experience outside of classroom laboratory.
• Knowledge of establishing microbiological limits and specifications based on USP and NSF guidelines.
• Good organizational skills.
• Good interpersonal skills.
• Excellent knowledge of PC software, MS Office, Word, Excel.
• Good written and verbal communication skills.
• Excellent Microbiology and Chemistry background, as well as the ability to apply this knowledge on practical applications.
• Excellent understanding and attitude towards cGMP and GLP, which will increase with job level.

Undergraduate degree in Biology, Chemistry, or related science degree. Education and background must include experience with knowledge of microbiology and chemistry, along with hands on experience with bacteria and wet chemistry.

Associate

Full-time

Science and Quality Assurance

Manufacturing and Pharmaceutical Manufacturing

• Medical insurance
• Vision insurance
• 401(k)
• Disability insurance