A Few Words About UsIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description Responsibilities- • Develops, and directs, and performs, lab activities related to experiments, studies, and projects in support of production, laboratory, or other groups • Researches sufficient information from all sources to fully understand study and needs. • Uses proper study design to effectively utilize resources to accomplish objectives • Plans studies, including timeline to follow and strategy in alignment with project objective o Compiles, analyzes, and interprets data leading to reports with conclusions and recommendations to appropriate personnel • Understands and follows GMP/GLP regulations. • May supervise non-exempt and contract personnel to achieve above goals. • Will work with senior scientific or management staff on major studies assuming scientific and GMP responsibility for a portion or portions of the study. Includes cross functional and cross site teams • Keeps abreast of technological advances specific to the laboratory and adopts and develops new techniques or scientific methods based on findings. • Provides instrumentation support for maintenance and trouble shooting. Develops and Manages the PM program for laboratory instrumentation. • Provides support and coaching for technology and method transfers • Maintains Standard Operating Procedures and recommends/validates/qualifies new methods and procedures for the laboratory. • Provides recommendations, conclusions and direction based on the data obtained from studies. • Completes Validation/Qualification methodology process reviews/verifications with support of compliance and/or re-validation requirements. • Provides support on all IOQ/PQs for laboratory instrumentation including document generation and IOQ/PQ completion. • Serve as Systems Administrator for Laboratory Computer systems, i.e. Empower 3, Omnic, LIMS. • Maintains a safe and clean working area. • Ability to communicate with-in department, with vendors, contractor sites and/or external customers for administrative and technical information. • Ability to prepare reports of experiments or studies that are grammatically and technically ready for regulatory audit. • Ability to construct and format reports for the intended audience (i.e. FDA, Production, Laboratory, Customers, or Sales). • May support FDA filings, assisting in compiling FDA responses, annual compliance reports, provide review for regulatory submissions. • May support release of API and finished goods including technical review of laboratory records, and COA generation and/or approval. Qualifications • BS or higher in related scientific field. Approximately 5-10 years laboratory experience preferably in an FDA regulated environment • Excellent attention to detail, excellent written and verbal skills. • Proficient in chemistry and analytical instrumentation including but not limited to HPLC, IC, GC, FTIR and UV-VIS spectroscopy • Experience with Wet Chemistry bench methods • Ability to troubleshoot issues as it relates to methods and equipment/instruments. • Experience with analytical method development and validation. • Ability to develop, run/direct, and report experiments, studies, and projects in support of laboratory, customer, validation, production, or other groups • Experience with instrumental software, i.e., Empower Chromatography Data System, Omnic Administrative Duties • Responsible for identifying and trending data. • Computer literate with MS Excel, Word, Access and PowerPoint #J-18808-Ljbffr