Consultant, QC Scientist, Pharmaceuticals
Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a Scientist who will be responsible for reviewing data of developmental, clinical, and commercial pharmaceutical and related products for accuracy and compliance.
Description
- Reviews analytical data, including raw data, of developmental, clinical, and commercial pharmaceutical and related products for accuracy and compliance with Client and GxP requirements.
- Initiate and monitors 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 pharmaceutical 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
Requirements
- 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 haves
- Experience with electronic document management systems – Veeva, CARA etc.
- Experience with investigation software (Trackwise preferred)
- Experience with laboratory information management systems (LIMS)
Term & Start
- 12-month contract, open to 12+ month extension
- 2 Video Interviews - Start 2 weeks from an offer
- Full-time, 40 hours/week (EST hours)
- Remote with onsite expectations a few times per year in Maryland
- Benefits included (Medical, Dental, Vision, 401k)
