Chemist III

Job Qualifications:

BS in Chemistry / BiochemistryMinimum 5-8+ years in FDA regulated environment working in QC laboratory.A foundation in analytical technique, with hands-on sample preparation and operation of analytical equipment and software required.Proficiency in analytical techniques such as HPLC, GC, FTIR, UV-Vis, and wet chemistry methods.Strong knowledge of GMP, GLP, and regulatory requirements (e.g., FDA, ICH guidelines).Excellent data analysis, problem-solving, and troubleshooting skills.Experience with laboratory information management systems (LIMS) is preferred.Experience with raw material, stability, in-process, and finished product testing.Experience with data analysis (MS Excel) and proficiency with MS Word required.Strong organizational, communication, and interpersonal skills.Attention to detail and a commitment to producing accurate, high-quality results.Ability to work independently and as part of a team in a fast-paced environment.Adaptability to changing priorities and deadlines.Strong analytical and critical thinking skills.Demonstrate good laboratory practices.Participate in research and development projectsGood oral and written communication skills.Flexible availability.POSITION RESPONSIBILITIES:

Perform analysis in the functional areas of analytical testing using modern analytical equipment such as HPLC, FTIR, UV, GC, ICP, as well as Wet Chemistry using titration techniques.Perform troubleshooting and maintenance on critical lab instruments (HPLC, GC, ICP, etc.)Provide analytical testing in support of production, analyzes Raw Material, In-Process, Finished product, Stability samples and investigation samples and analyzes and interprets the test data and document result in a timely manner.Thorough understanding and compliance with FDA cGMPs / cGLPs / USP / ICH / SOPs / Test Methods and other recognized standards.Support and be the lead in Analytical and Chemical test method development and test method validations as necessary.Writing of SOPs, test methods, study protocols, reports and reviews.Training of lab analysts on analytical test method procedures and usage of equipment and documentation.Share in the responsibilities of housekeeping (i.e. glassware, waste, retains, lab waste disposal, etc.).Communicate lab test data, data review, and reporting of OOS / QR / OOT test results to the lab manager.Provide ideas/feedback for areas where efficiency can be implemented in the lab through the 5S process improvement program.Support all general safety, and pharmaceutical compliance requirementsCoordinate with calibration services in the upkeep of lab instrumentationInitiate and complete analytical test methods associated with raw materials, finished products, and lab instrumentation.Mentor other chemists in the QC laboratoryLead laboratory investigation efforts and draft final reports for review by managementAssist with annual management review metrics for QC laboratory functions.PHYSICAL REQUIREMENTS:

Employees are required to wear eye protection and lab coats while in the labWork safely and follow all OSHA regulations and company safety policies and procedures.Ability to frequently lift and/or move up to 25 lb.Ability to occasionally lift and/or move up to 35 lb.Ability to regularly stand, sit and walk to perform tasks.