Scientist Consultant (QC/AS) III, Pharmaceuticals

Summary

Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a Scientist Consultant (QC/AS) to support the client studies of developmental, clinical, and commercial pharmaceutical and related products

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 clients 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

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)

Term & Start

• 12 month contract, open to 12+ month extension
• 2 Video Interviews - Start 2 weeks from an offer
• Full-time, 40 hours/week
• Hybrid – Rockville, MD
• Benefits included (Medical, Dental, Vision, 401k)