Position Summary: Testing pharmaceuticals, vitamins and herbal products using HPLC, ICP, FTIT, NIR, UV-VIS and wet chemistry per USP, AOAC, FCC, BP (British Pharmacopeia) and internal procedures. Properly disposes of waste chemicals based on OSHA requirements.
Position Scope: Handles approximately 15 - 35 analytical tests per week
- Works with lab instruments, e.g. HPLC, AA, PDA, RI detection methods, ICP and ICP-MS to perform analytical tests. Also works with chemicals and reagent solvents during the day.
- Records the raw data and results from scientific test results.
- Reports any lab instruments malfunction to Lab Manager.
- Prepares and files all Quality Control documents, e.g. Certificate of Analysis (COA) Deviations, Out of Specification (OOS) reports.
- Reviews testing and notebooks to prepare bulk product release.
- Conducts daily calibration of balances and Ph meter. Calibrates an expiration date for all product labels based on shelf life expectancy.
- Disposes of waste chemicals appropriately.
- Checks raw materials and finished product potencies.
- 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.
- Assists in 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.
- Clean working space, desk, equipment/glassware and whole lab.
- Qualification and maintenance of primary and secondary standards of raw material and finished products.
- Maintains R&D raw material inventory, laboratory notebooks, equipment logs and maintenance schedules.
- Prepares specification for raw materials and finished products. Conducts in process testing of manufactured samples.
- Conducts minor repairs of lab instruments and other apparatus.
- 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.
- 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.
Experience and Skills:
- Three years of Pharmaceutical lab experience and good familiarity with HPLC, ICP and ICP-MS as well as good mechanical aptitude.
- Good organizational skills.
- Good interpersonal skills.
- Excellent knowledge of PC software, MS Office, Word, Excel.
- Good written and verbal communication skills.
- Excellent Chemistry background as well as practical application of the technical knowledge.
- Excellent understanding and attitude towards cGMP and GLP, which will increase with job level.
Education and Certifications:
- Undergraduate degree in Chemistry