Scientist Consultant (Princeton)

Consultant, Scientist Consultant (QC/AS) III, Pharmaceuticals12-month ContractLocal to Princeton, NJDuties / Expectations of RoleReviews analytical data, including raw data, of developmental, clinical, and commercial pharmaceutical and related products for accuracy and compliance with the client's GxP requirements.Initiate and monitor stability studies of developmental, clinical, and commercial pharmaceutical and related products tested by contract laboratories.Reviews, enters, and maintains stability data for developmental, clinical, and commercial pharmaceuticals and related products.Create studies in LIMS for multiple projectsEnter or review sample test result data in LIMSAssists in technical investigations; enters deviations and investigations into TrackwiseMaintain and manage analytical testing documentation, including protocols, reports, and data, in compliance with good documentation practices (GDP) and data integrity standards.Prepare stability reports and summaries for inclusion in INDs, NDAs, and regulatory submissions, ensuring accuracy, completeness, and adherence to regulatory requirements.Use descriptive statistical techniques to organize and summarize dataBased on project needs, use statistical analysis techniques to identify patterns and trendsCreate graphs, profiles, and reports of testing and/or stability data and statistical analysisAssist the project team in making informed business decisions based on data insightsRequired experience:Bachelor's degree in chemistry or related science + 5 years work experience in a GXP environment focused on analytical laboratory testing of pharmaceuticals and related materialsFamiliarity in GMP environment focused on analytical laboratory testing, including HPLC, Dissolution, etc.Experience with MS Office, especially MS ExcelExperience in data reviewNice to haveExperience with electronic document management systems – Veeva, CREDO, etc.Experience with investigation software (Trackwise preferred)