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TOLMAR Inc. Research Associate I in Fort Collins, Colorado

Purpose and ScopeUnder direct supervision, the analyst performs sample analysis, datareview, document review, and method development. The analyst uses in-housestandard operating procedures and pharmaceutical industry knowledge. Theanalyst fosters an environment of safety and company culture.Essential Duties and ResponsibilitiesLearn to apply regulations for drugs and medical devices, including USP,ICH and FDA regulations for cGMP and GLP.Adhere to validated test methods, standard operating procedures, andapplicable industry guidance.Perform routine sample analyses in support of GLP and/or RandD stabilityprotocols.Analyze samples of drug product, drug substance, and/or excipient(s).Assist other departments in analyzing samples, as requested.Maintain and review laboratory notebooks according to cGMP standards andin-house standard operating procedures (SOPs).Record detailed observations. Tabulate, analyze, and interpret data fromanalytical tests.Assist in analytical test method development, qualification, and validation.Learn to perform equipment troubleshooting, maintenance and minor repairs.Assist the Quality Control (QC) laboratory in troubleshooting test methodissues.Write and review brief technical reports, summaries, protocols, testmethods, standard operating procedures, and other documents for productdevelopUse technical discretion in the execution of experiments that contribute toproject strategies.Participate in required trainings.Participates in required annual hazardous waste training. Hazardous wasteinvolvement may include but is not limited to container and tank managementand inspections, generation of hazardous waste as a part of production orsampling processes, and transfer of hazardous waste between lab procedurearea, satellite accumulation, and storage. Responsible for dailyactivities and supervising staff that are hazardous waste generators and/orhandlers. Respond to spills according to the Chemical Spill Responseprocedure.Perform other related duties as assigned.Knowledge, Skills and AbilitiesKnowledgeFamiliar in the operation of analytical laboratory instruments, such as:HPLC, GC, FTIR, pH, UV-Vis, TLC, Karl Fischer titration, and viscosity.Basic understanding of sample preparation techniques.Use of FDA regulations, USP, NF, ICH, EP, and their application inthe laboratory.Basic understanding of technical writingSkillsBasic laboratory and wet chemistry techniques. (e.g. weighing, volumetricglassware, titrations, etc.).Understanding of equipment troubleshooting, maintenance, and repairs.Basic understanding of test method development.Effective written and oral communication skills.Understanding of electronic document management system(s).Basic use of word processing and spreadsheet programs. Proficient with MSOffice.Experience working with computer systems for sample tracking, laboratoryequipment, and raw data handling.AbilitiesLearn and apply new techniquesAttention to detail. Accurate and consistent in data compilation and review.Learn to work independently, for example by following test methods andprocedures.Core ValuesThe Research Associate I is expected to operate within the framework ofTolmar's Core Values:Consistently operate with the highest standards of ethics and compliance.Take ownership of your actions, success and setbacks.Respect each other and understand that honest collaboration is at the heart ofour company success.Go the extra mile to make things happen.Be committed to all we do and the patients we serve.Embrace change with enthusiasm.Strive to learn about and understand the needs of customers and patients,and take action with great speed and efficiency no matter the task. Education and ExperienceBachelor's degree in chemistry or related field.Analytical laboratory experience, in a pharmaceutical environment ispreferred.Working ConditionsLaboratory setting. Will be exposed to solvents, bio-hazardous materials,hazardous waste, and pharmaceutical substances.Compensation and BenefitsAnnual Pay Ran

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