Provides routine analyses in a chemistry or microbiology environment by following standard practices. Performs analytical methods as assigned for testing on raw materials, samples, stability, environmental, production intermediates, and/or human cells. Supports internal development and/or manufacturing operations. Makes detailed observations and reviews, documents, and communicates test results.
- Conducts routine chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples by internally developed and compendial test methods.
- Executes validated test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis, utilizing HPLC, GC, LC/MS, dissolution, spectroscopy, and/or traditional wet chemical testing.
- Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems.
- Performs daily instrument calibrations / verifications as required.
- Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results.
- Records and reports results of analysis in accordance with prescribed lab procedures and systems. Assists in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites.
- Contributes to writing of SOPs if needed.
- Cleans and organizes work area, instrumentation, and testing materials.
- Cleans HPLC and dissolution systems after use.
- Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
- Maintains the necessary compliance status required by company and facility standards.
Bachelor's degree in Chemistry.
- Five years previous related experience.
- Experience performing chemical tests with chromatographic, spectroscopic, or other analytical technique preferred.
Equivalent combinations of education, training, and relevant work experience may be considered.
Good knowledge and understanding of basic instrumental technologies. Knowledge of qualitative and quantitative chemical or microbiological analysis. Awareness of quality and regulatory requirements in the pharmaceutical industry. Good problem solving skills and logical approach to solving scientific problems. Demonstrable interpersonal and communication skills (both oral and written). Ability to read and interpret technical procedures and governmental regulations. Ability to apply mathematical operations to such tasks as determination of test reliability, analysis of variance, and correlation techniques.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.
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