Essential Functions and Responsibilities:
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Evaluates the chemical and physical properties of various substances
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Follows the instructions and pre-established guidelines to perform the functions of the job
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Responsible for routine chemical analysis work and reviewing involving pharmaceutical raw materials, process intermediates and finished products following GMPs
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Prepare volumetric test solutions and mobile phases
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Utilize knowledge of High-Performance Liquid Chromatography (HPLC), Inductively Coupled Plasma (ICP), and titration techniques.
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Maintains appropriate documentation (records and lab notebooks) as required by SOP’s and cGLP’s
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Audits raw data results and laboratory documentation
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Calculates, interprets and review test results. Prepare test reports and review lab notebooks
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Performs OOS investigations as described in the SOPs to establish integrity of data Phase I & Pase II)
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Operates, maintains, calibrates and qualifies equipment in assigned areas
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Able to write and execute protocols with minimum supervision and SOPs
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Assist in investigations, development and validation to method development.
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Disposes waste according to Environmental Protection Agency (EPA) regulations and transfer of gas cylinders
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Follows laboratory safety rules
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Assists in the process of methods development
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Other duties as assigned by the immediate Supervisor
Qualifications:
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Bachelor’s degree in Chemist or Science discipline and/or equivalent work experience
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1 - 3 years experience
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Bilingual (English and Spanish) preferred
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Basic use of Excel, Word and quality management systems.
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Knowledge of lab equipment (HPLC, ICP-MS, GC, UV, FT NIR)
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Experience and knowledge in Methods Validation
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Knowledge in GMP regulations and safety practices
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Knowledge of GLP practices.
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Availability to work rotating or night shifts.
Commitment to good cleaning, safety, and documentation practices