QC Chemist

Description:

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. Perform additional duties and responsibilities designated by the supervisor on the need basis after receiving the required training. RK Pharma Inc is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.