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