Scientist Consultant

Scientist Consultant at GForce Life Sciences Scientist Consultant at GForce Life Sciences in Rocky Hill, New Jersey Posted in 4 days ago.

Type:

full-time

Job Description:

Consultant, Scientist Consultant (QC/AS) III, Pharmaceuticals 12-month Contract Local to Princeton, NJ Duties / Expectations of Role Reviews 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 projects Enter or review sample test result data in LIMS Assists in technical investigations; enters deviations and investigations into Trackwise Maintain 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 data Based on project needs, use statistical analysis techniques to identify patterns and trends Create graphs, profiles, and reports of testing and/or stability data and statistical analysis Assist the project team in making informed business decisions based on data insights Required 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 materials Familiarity in GMP environment focused on analytical laboratory testing, including HPLC, Dissolution, etc. Experience with MS Office, especially MS Excel Experience in data review Nice to have Experience with electronic document management systems - Veeva, CREDO, etc. Experience with investigation software (Trackwise preferred)