Job Description

Summary

Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a Scientist Consultant (QC/AS) to support the client's 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 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)

Term & Start

• 12-month contract - option to extend
• Remote
• Paid Federal Holidays for W2
• Health Insurance available

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