What are the responsibilities and job description for the Quality Control Scientist position at GForce Life Sciences?
Consultant, 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
• Remote with some travel to Rockville, MD
• Benefits included (Medical, Dental, Vision, 401k)
