Pearl River
Job DescriptionDescription: RK Pharma Inc, a vertically integrated pharmaceutical company with our main manufacturing site in Pearl River, NY, is seeking a Quality Control Chemist to work with our growing Quality Teams as we scale towards commercial manufacturing in the next upcoming months. As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team. Requirements: If this sounds interesting to you, it’s probably because up to this point you have: • Bachelor of Science of higher, • 0-3 years of quality Control experience, preferably in a pharmaceutical, manufacturing, or regulated environment., • Familiarity with cGMP, GDP, and standards., • Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint) and experience with ERP or document management systems (e.g., SAP, Master Control)., • Excellent organization, time management, and communication skills. The main responsibilities for this position are: • Perform daily verification /performance check of the QC analytical instruments such as Analytical balance, Microbalance, KF titrator, KF coulometer, Auto titrator etc.,, • Perform calibrations of all the QC analytical instruments/equipment’s as per the calibration calendar schedule or when required., • Perform Instrument/ equipment performance qualification as and when required., • Maintain inventories of chemicals, Standards, samples etc.,, • Operation, calibration, maintenance and qualification of all analytical instruments such as HPLC, GC, TOC, UV, IR, automatic titrator, dissolution equipment, etc., • Follow the procedures as per the SOP’s/ guidelines., • Perform Sampling of raw materials, drug substance, packaging components, stability samples, cleaning samples, In-process samples and finished products., • Perform analytical tests and wet chemistry tests on raw materials, drug substance, packaging components, stability samples, cleaning samples, In- process samples and finished products in compliance with the STP and SOP’s., • Follow and document all test results under GLP, GDP, GMP and Lab Safety guidelines., • Document test results, problems and other issues, perform troubleshooting of issues that arise during analysis., • Logging various samples received to QC as per the SOP into their respective log books., • Monitors Stability chambers, Photostability chamber, freezers, refrigerators etc., • Performs Stability samples loading/charging and pull-out according to the stability calendar., • Record the results and prepares CoA to be released in a timely manner., • Perform analysis using various software’s such as Empower, Tiamo, Spectrum two, Flex etc., • Write and perform investigation of out of specification results., • Train other QC chemists in a timely manner on all the general Laboratory SOPs and test methods., • Preparation and review of Standard Operating Procedures, specifications and STP’s for Raw materials, Packaging components, drug substances and finished products (based on ICH/Pharmacopeial reference)., • Preparation and execution of protocols for Method Validations, Method Transfers, Cleaning Validation, Raw material qualifications, Stability studies and any other studies., • Maintains lab, instruments, logbooks and notebooks at all times., • Maintains lab instruments and performs calibration/preventive maintenance to ensure proper working order and troubleshoot when necessary.
