The Quality Chemist conducts research, analyzes and experiments with all pharmaceutical dosage forms and raw materials for purposes of product development, quantitative analysis to determine how much of one substance is mixed with another, process applications and qualitative analysis to develop and improve products.
The position analyzes organic and inorganic materials to determine their chemical and physical makeup in order to ensure compliance with FDA requirements for release to the marketplace.
Evaluates the chemical and physical properties of various organic and inorganic substances such as active and in-active raw materials in order to verify the compliance with the established specifications.
Provokes changes in the composition of the materials using a variety of measures including dissolution testing, spectroscopic and wet chemistry techniques.
Relies on verbal and written instructions and pre-established guidelines to prepare and maintain reports based on scientific deductions.
Validates analytical test methods, critically evaluates and audits data, writes technical analytical reports and procedures.
Test samples to insure compliance with FDA and cGMP requirements according to approved written procedures and specifications.
Perform, assay, assisting in the validation of assays, and writing test methods.
Instrumentation includes high level of complexity and difficulty eg GC, HPLC
Responsible for biological and / or chemical evaluation of final product, intermediate products, raw materials, and production facilities.
Requires labeling packaging or movement of hazardous materials within the facility and must comply with local, state and federal regulations regarding disposal of these types of toxics.
Performs a variety of tasks. May lead and direct others for specific smaller projects. A certain degree of creativity and latitude is expected.
Checking / reviewing of analytical data if required by following test methods and related SOP’s.
Experience and Qualifications
Bachelors degree in Chemistry or related science field with four (4) plus years lab experience in a pharmaceutical chemical or related industrial experience;
preferably solid dosage forms manufacturing.
Basic knowledge of computers using MS Office, MS Outlook and business software systems commonly used in the pharmaceutical industry required.
Need input here on level of computer skills and applications required).
Knowledge, Skills and Abilities
Knowledge and experience of applicable FDA regulatory standards and requirements for the solid oral dosage manufacturing required.
Knowledge of analysis of pharmaceutical dosage forms and raw materials utilizing HPLC, GC, UV, TLC, dissolution testing, spectroscopic and wet chemistry techniques is a plus.
Advance level of written and verbal communication skills with the ability to read, technical procedures or governmental regulations.
Ability to write reports, and required documentations.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form. Must possess initiative and trouble shooting ability.