QC Chemist, Raw Materials

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    "requisitionDescription": "<div><p id=\"isPasted\"><strong>Job Overview:</strong></p><p>Under minimal supervision of QC management, the QC Chemist performs physical and chemical testing on raw materials, in-process and finished products, as well as stability samples. &nbsp;Utilizes established methods and standard operating procedures and laboratory equipment to perform testing of materials. &nbsp;Prepares high quality written documentation, such as notebooks, logbooks, standard operating procedures (SOPs) and LIMS reports. &nbsp;Trouble shoots analytical equipment. &nbsp;Provides training on analytical methods and new technologies.&nbsp;</p><p><strong>Responsibilities:</strong></p><ul><li>Performs analytical testing of raw materials, in-process materials, finished products and stability samples.</li><li>Operates laboratory equipment such as balances, pH meters, hardness testers, particle size analysis, LOD, Karl Fischer, Melting Point, etc. in accordance with laboratory SOPs and test methods.</li><li>Effectively performs routine testing using HPLCs, GCs, UV-VIS, FT-IR and ICP-MS equipment in accordance with SOPs and test methods.</li><li>Performs data analysis and evaluation of test results.</li><li>Prepares reports and reviews data.</li><li>Maintains accurate records of test data, maintains laboratory notebooks and logbooks in accordance with company guidelines and GDPs.</li><li>Assists in writing and revising SOPs and tests methods as needed.</li><li>Follows documented procedures: SOPs, test methods, and transfer protocols.</li><li>Performs routine maintenance, calibration, and performance verification on applicable instruments.</li><li>Performs investigation activities and writes deviation and investigation reports.</li><li>Suggests and writes CAPAs.</li><li>Follows lab safety procedures.</li><li>Perform other duties as assigned.</li></ul><p><strong>Qualifications:&nbsp;</strong></p><ul><li>Bachelors in chemistry or related physical/biological science, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.</li><li>Minimum of 3 years&rsquo; experience in Pharmaceutical Analysis&nbsp;</li><li>Must understand analytical chemistry.</li><li>Demonstrated knowledge of cGMP regulations and ICH guidelines&nbsp;</li><li>Computer literacy and ability to use data acquisition and processing software, such as EMPOWER 3</li><li>Demonstrate the ability to read, analyze, and interpret USP/NF methods, SOPs and technical procedures manuals, and batch records.</li><li>Demonstrate the ability to define problems, collect data, establish facts, and draw valid conclusions; interpret an extensive variety of technical instruction in mathematical or diagram form.</li><li>Knowledge of basic laboratory practices, methods, and techniques</li><li>Demonstrate the ability to carry out work assignments communicated orally or in writing.</li><li>Demonstrate familiarity with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities.</li><li>Demonstrates the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.</li><li>Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.</li><li>Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.</li><li>Must be able to comprehend and follow all applicable SOPs.</li><li>Demonstrate ability to acquire the appropriate knowledge from resources on with electronic Quality Management Systems such as MasterControl and Trackwise.</li><li>Demonstrate understanding of the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.</li><li>Good understanding of cGMPs, industry, and regulatory standards and guidelines.</li><li>Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.</li><li>Demonstrate the ability to portray the appropriate level of integrity and professionalism.</li><li>Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.</li><li>Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.</li><li>Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.</li><li>Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.</li><li>Results-oriented and efficient.</li><li>Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.</li><li>Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).</li><li>Demonstrate the ability to work well in a cross-functional team environment.</li><li>Must communicate fluently in English and have legible handwriting.</li></ul><p><strong>Physical Demands:&nbsp;</strong></p><ul><li>Ability to travel between and within facilities to visit staff, operations, and projects, as needed.</li><li>Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).</li><li>Ability to lift up to 40 pounds on occasion.</li><li>Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).</li></ul></div>\n",
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