REGULAR FULL TIME Professional Putnam, CT, US 1 Attachments Salary: $80,000.00 Annually SUMMARY OF JOB DUTIES Performs sample analysis using the LC/GC and other analytical instruments on a daily basis using in‑house or client’s test methods and USP/NF or EP general chapters and monographs Assists with analytical test methods development for trace product analysis, assays, impurities of final products, as applicable Drafts method validation, verification, or method transfer protocols and reports Assists in assays and investigations/troubleshooting problems which support the raw material, in‑process and final product release in accordance with specifications and procedures Assists in the implementation of new laboratory procedures Assists and/or performs calibration and maintenance of laboratory equipment and instrumentation including the oversight of contract support for these activities, if required Prepares and/or reviews standard operating procedures, technical reports, specifications, stability protocols, and analytical test records, as applicable Prepares statistical analysis of results and assists with technical reports Identifies and corrects nonconformances for laboratory procedures and from analytical testing Assists with problem solving within the department and as a member of cross functional teams Promotes quality achievement and performance improvement Other duties as assigned Observes and maintains quality systems, policies and procedures that ensure compliance to cGMP, GLP, ISO 9001/13485, FDA (i.e. 21CFR11, 820, 210, 211) and other applicable standards. AREA OF RESPONSIBILITY Analytical testing on daily basis MANDATE (INCLUDING FINANCIAL MANDATE) Analytical testing and reporting for release of raw materials, finished products and stabilities JOB PROFILE (VALUABLE PERSONAL SKILLS/ BEHAVIOR) Background and understanding for working in a regulated (ISO, FDA and EU cGMP) environment. Knowledge in utilizing LC/GC and common laboratory instruments. Other techniques include: FTIR, UV-Vis spectrophotometry, dissolution, pH, viscosity, moisture, titrations, and other wet and instrumental compendial testing Knowledge of pharmaceutical analytical testing is highly desirable. Knowledge of plastics manufacturing and associated analytical testing is highly desirable. Demonstrates interpersonal, communication, and motivation skills. Attention to detail is crucial in this position. Flexible in handling multiple and changing work assignments. Ability to effectively present information and respond to questions. Knowledge of Excel, Word, PowerPoint. Knowledge of analytical chemistry and other scientific disciplines generally attained through studies resulting in a degree. M.S. or B.S. (minimum), in chemistry, science, biochemistry, or its equivalent is preferred. A M.S. with a minimum of 1 year’s experience or a B.S. minimum of 2 years’ experience in pharmaceutical/medical device regulated environment. #J-18808-Ljbffr
Job Posting Organizational Location: This position is with the Department of Homeland Security, within U.S. Customs and Border Protection, Office of Field Operations, New Orleans Field Office, Area Port of Mobile, Port of Pascagoula, MS.
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