QC Chemist II

QC Chemist II Title: QC Chemist II Location: Largo, FL Industry: Pharmaceutical & Chemical Manufacturing Schedule: 2nd shift, Monday-Friday, 3pm-11pm Pay Rate: $29/hr-$31/hr depending on experience plus $2.00 shift differential (for worked hours only) Employment Type: Contract with possibility to go permanent PRIMARY PURPOSE Transfer and testing of HPLC, Gas Chromatography, ICP and AA methodology. Must have extensive cGMP experience and be able to provide leadership and mentoring to Chemist I and Chemist II in QC Laboratory. Must have thorough understanding of Good Laboratory Practices and Good Documentation Practices, as well as compendial methodology. Must have experience in writing Standard Operating Procedures, Protocols and Reports. MAJOR DUTIES AND RESPONSIBILITIES Perform all the activities for transfer, and testing analytical methods. Revise Test Methods and SOPs. Testing of incoming materials, using compendial test methods (USP, PhEUR, JP) Testing stability samples, in process samples and finished product testing, using a variety of techniques, such as HPLC, GC, AA, ICP, UV/Vis, etc. Accurately records raw data and analyzes, as well as calculates and interprets the results. Responsible for out of specification test results, investigation, and implementation of corrective actions. Ensure testing is performed accurately and in compliance with GLP, cGMP, cUSP, SOP and other approved test methods and protocols. Maintain analytical reagents in laboratory including but not limited to: inventory, current MSDS, PPE required for handling, waste generation and disposal. Assist Validation teams in cleaning validation activities. Support laboratory troubleshooting needs by interacting with vendors, customers and other relevant SMEs. Promote GMP and safety throughout the facility. Promote continuous improvement and customer satisfaction. Follow-up on OOS and CAPAs to verify compliance. Potential exists for exposure to potentially harmful chemicals. Participate in other activities as assigned by the Lab Manager or VP Quality. QUALIFICATIONS Bachelor's degree in Chemistry or related discipline. Must have two or more years experience working in an analytical laboratory in an FDA regulated industry (pharmaceutical or related industry) Must have HPLC, GC, cGMP ICP, related compound testing, assays, dissolutions, and additional lab testing / bench work experience Knowledge of Compendia testing. Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes use of chemicals and their interactions, danger signs, production techniques, and disposal methods. Knowledge of raw materials, production processes, quality control, and other techniques for maximizing the effective manufacture of goods. Working knowledge of FDA regulations for laboratory testing and disposition. Ability to use a personal computer and peripheral equipment to accurately enter/analyze data and produce reports. Knowledge of chemical safety and protective equipment. Expertise in various analytical equipment and techniques utilized in an analytical laboratory including but not limited to pH, viscosity, specific gravity, infrared spectroscopy, HPLC, GC, ICP, UV/VIS, atomic absorption. Ability to establish priorities, work independently, productively, and proceed with objectives without supervision. Ability to handle and resolve recurring problems. Understanding the implications of new information for both current and future problem-solving and decision-making. Ability to communicate effectively, concisely in a professional manner with clients and others. Ability to work in a dynamic fast paced environment-sometimes rapidly shifting priorities. Ability to concentrate in such an environment and perform quality work. Must be able to lift up to 15 pounds. Normal office environment exposure to chemicals and/or other potential hazards. EOE/ADA #J-18808-Ljbffr