Job Description

Job Description

Essential Functions and Responsibilities:

• Evaluates the chemical and physical properties of various substances
• Follows the instructions and pre-established guidelines to perform the functions of the job
• Responsible for routine chemical analysis work and reviewing involving pharmaceutical raw materials, process intermediates and finished products following GMPs
• Prepare volumetric test solutions and mobile phases
• Utilize knowledge of High-Performance Liquid Chromatography (HPLC), Inductively Coupled Plasma (ICP), and titration techniques.
• Maintains appropriate documentation (records and lab notebooks) as required by SOP’s and cGLP’s
• Audits raw data results and laboratory documentation
• Calculates, interprets and review test results. Prepare test reports and review lab notebooks
• Performs OOS investigations as described in the SOPs to establish integrity of data Phase I & Pase II)
• Operates, maintains, calibrates and qualifies equipment in assigned areas
• Able to write and execute protocols with minimum supervision and SOPs
• Assist in investigations, development and validation to method development.
• Disposes waste according to Environmental Protection Agency (EPA) regulations and transfer of gas cylinders
• Follows laboratory safety rules
• Assists in the process of methods development
• Other duties as assigned by the immediate Supervisor

Qualifications:

• Bachelor’s degree in Chemist or Science discipline and/or equivalent work experience
• 1 - 3 years experience
• Bilingual (English and Spanish) preferred
• Basic use of Excel, Word and quality management systems.
• Knowledge of lab equipment (HPLC, ICP-MS, GC, UV, FT NIR)
• Experience and knowledge in Methods Validation
• Knowledge in GMP regulations and safety practices
• Knowledge of GLP practices.
• Availability to work rotating or night shifts.

Commitment to good cleaning, safety, and documentation practices

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