Job Information
Leading Pharma LLC QC Chemist in Fairfield, New Jersey
Job Duties: Perform chemical analysis and test raw materials, stability samples, bulk formulations, and finished product with quality compliance (60%); Perform analytical testing and data review in accordance with cGMP requirements (25%); Provide cGMP compliant laboratory technical support to Manufacturing/Operations in the form of method validation, cleaning validation, method transfer, testing, and documentation (5%); Provide data entries in laboratory logbooks (5%); Perform peer review of co-worker’s notebook to ensure compliance to SOP’s and cGMP’s (5%). Requires: Bachelor’s degree in Chemistry, Chemical Engineering or related field/foreign equivalent plus 2 years of experience as Quality Control Chemist, Quality Control Analyst, or related in a pharmaceutical laboratory and 2 years of experience (simultaneous and concurrent with the above-listed experience) in a pharmaceutical laboratory with: Performing quality assurance and cGMP compliance activities for manufacturing site, warehousing/distribution functions, and label control; Participating in Out-of-Specification processes; Operating and maintaining pharmaceutical laboratory equipment, including analytical balances, pH meter, HPLC, UPLC, UV/Vis spectrophotometer, GC, Headspace-gas chromatography, Infrared Spectroscopy, KF Titrator, and dissolution apparatus; Utilizing Waters “Empower 3” software; Ensuring operations comply with current GMP and GLP standards, as well as the USP, EP, BP, and ICH Guidelines for analytical methods used in Quality Release and Stability applications. To apply, please email resumes toHR@leadingpharma.com