Work ScheduleStandard (Mon-Fri)Environmental ConditionsLaboratory SettingJob DescriptionThe R&D Scientist II-Reviewer independently performs complex data reviews in support of validations, development testing, protocols and reports. In addition, the reviewer is to provide necessary support of in-process, release and stability testing. The reviewer functions are also dedicated to laboratory Integrity Compliance activities as mandated by corporate standards.Key Responsibilities:Perform cGMP analytical data review for various techniques to ensure adherence to established procedures, analytical standards, GVLs and SOPsDetermine if reported data meets specification or expected standardsVerify that data is correctly entered into its designated software systems for approval (LIMS/SLIM)Trend data where applicable to ensure requirements are metEnsure that all laboratory testing and activities are carried out in compliance with regulations, ICH guidelines, and USP/EP Pharmacopeia, GMP and data integrity requirementsAssist in trainings as an SMECommunicate with Project Lead/Managment concerning project status and/or concernsDemonstrate ability to work as a team player and in a fast-paced environmentMust be able to set project priorities and time management in order to maximize productivityActively participate in ongoing trainings and seek out opportunities to increase contributions for development of skills and responsibilitiesWork closely with analyst to complete correctionsMight Author and/or review: OOS investigations, Deviations and Change Controls, CAPA, technical reports, Protocols and validation summaries , SOPsEnsure all job-related safety training and compliance requirements are metQualifications:Associates degree required -bachelor’s degree preferred) All degrees must be from a scientific discipline or Associates degree with 5 years of pharmaceutical experience and 3 or more years of reviewing data for cGMP compliance orBachelor’s degree with 3-5 years of pharmaceutical experience and 2 or more years of reviewing data for cGMP complianceAdvanced knowledge and experience in EmpowerAdvanced knowledge in HPLC, UV, FT-IR, UV, Karl Fischer Titration, IEF (Preferred), ELISA (Preferred), CGE (Preferred), Dot-Blot (Preferred)Demonstrate knowledge in method validationExperience with analytical method development, validation, transfer, and verification for drug products and raw materials is advantageousExperience testing for assay, impurities, content uniformity, potencyData trending and interpretation of analytical resultsStrong knowledge of GMP, GLP regulatory requirementsStrong organizational, communication, and leadership skillsAbility to manage multiple priorities and meet deadlinesProficiency in Microsoft Office applicationsDemonstrated ability to work independently and collaborativelyFluent in English