Analytical Data Review Scientist
On-site · Houston, Texas, United States
Job Summary
The Analytical Data Review Scientist is responsible for analyzing, tracking, and reporting laboratory data to support quality and compliance objectives. Key responsibilities include reviewing analytical data and laboratory worksheets for accuracy and compliance, performing technical reviews of investigations, maintaining laboratory documentation, and supporting audits. The role requires technical expertise in data analytics and laboratory processes, including proficiency with analytical instruments and LIMS systems. Candidates should possess a Master's degree in a relevant field and at least 2 years of experience in a regulated laboratory environment.
Required Qualifications
- Bachelor’s or Master’s degree in Chemistry, Analytical Chemistry, Biochemistry, or a related science field
- Minimum 2 years’ experience in a regulated pharmaceutical analytical laboratory or equivalent combination of education and experience
- Strong knowledge of cGMP, cGLP, ISO 17025, USP, A2LA, and data integrity principles
- Experience with laboratory documentation, technical review of analytical data, and OOS/OOT investigations
- Excellent attention to detail, organizational, and communication skills; ability to work independently and collaboratively
- Proficiency in Microsoft Office
Desired Qualifications
- Proficiency with analytical instruments (HPLC, UPLC, GC, UV/Vis spectrophotometer)
- Experience with LIMS (e.g., Empower, EagleTrax) and electronic data review
- Experience with method development, validation, and transfer
- Familiarity with regulatory submissions and quality systems
- Knowledge of emerging analytical technologies and pharmaceutical testing applications
- Exposure to multiple laboratory workstations, cross-functional operations, and providing technical consultation
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