Scientist, Data ReviewPosition SummaryWe have an opportunity for a Scientist, Data Review to join our team. This role is responsible for reviewing and verifying analytical data for raw materials, packaging components, in-process, finished product, and stability testing. You will ensure accuracy, completeness, and compliance with USP, EP, JP, and internal cGMP requirements. The position plays a key role in maintaining data integrity and meeting regulatory expectations.
Shift: Monday - Friday, 8:00am to 5:00pm
Location: Morrisville, NC
100% Onsite
The Role- Perform independent Level 2 review of analytical data for raw materials, packaging components, in-process, finished product, and stability samples
- Review and verify analytical test results generated using techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Fourier Transform Infrared Spectroscopy (FTIR), Ultraviolet (UV), and wet chemistry in accordance with USP, EP, JP, and in-house methods
- Conduct audit trail reviews to ensure all data changes are traceable, justified, and compliant with data integrity (ALCOA+) requirements
- Review raw data, calculations, and documentation for accuracy, completeness, and data integrity compliance
- Verify system suitability, instrument performance, and method compliance during data review
- Support investigations including Out of Specification (OOS), Out of Trend (OOT), and deviations, and implement corrective and preventive actions (CAPA)
- All other duties as assigned
The CandidateMinimum Requirements- Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or a related field of study
- Minimum 5+ years of experience in a pharmaceutical Quality Control (QC) laboratory environment
- Strong experience in data review, raw material testing, and compendial methods (USP/EP/JP)
- Knowledge of chromatographic and analytical techniques including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and Fourier Transform Infrared Spectroscopy (FTIR)
- Strong understanding of current Good Manufacturing Practices (cGMP), data integrity, and regulatory expectations
- Proficiency in reviewing data from HPLC, GC, FTIR, Ultraviolet (UV), and wet chemistry techniques
- Must be able to wear safety glasses and a respirator when required
- Must have 20/20 vision (with or without corrective lenses)
Preferred Skills & Background- Familiarity with laboratory systems such as Empower, Laboratory Information Management System (LIMS), and TrackWise
Why You Should Join Catalent- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- Competitive paid time off plus 8 paid holidays
- Community engagement and green initiatives
- Medical, dental, and vision benefits effective day one of employment
- Tuition Reimbursement
