Reviewer, QA Data

POSITION: QA Data Reviewer

DUTIES:

• Oversee all Analytical and Quality Control (QC) operations, ensuring full compliance with cGMP, FDA, EMA, and ICH regulatory guidelines.
• Perform analytical data review, ensuring accuracy, completeness, and timely evaluation of raw data, analytical results, and laboratory documentation.
• Ensure data integrity and regulatory compliance by implementing robust review procedures, maintaining audit trails, and enforcing documentation standards.
• Collaborate cross-functionally with Quality Control (QC), Quality Assurance (QA), and Research & Development (R&D) teams to support analytical method validation, transfer, and

troubleshooting.

• Review and approve critical analytical documentation, including Certificates of Analysis (CoAs), method validation/verification protocols and reports, and stability study summaries.
• Support investigations related to out-of-specification (OOS) results, out-of-trend (OOT) data, deviations, and other laboratory non-conformances.

• Drive continuous improvement initiatives across QA/QC systems and processes to enhance operational efficiency and ensure audit readiness. •Operate and troubleshoot HPLC, UPLC,

and GC systems, with hands-on proficiency in analytical method development, validation, and routine analysis.

• Use and navigate LabWare LIMS, Waters Empower software.
• Use Mettler Toledo LabX®- for precision weighing and data integration with analytical balances and titrators, Thermo Scientific OMNIC® (FT-IR) - for spectral acquisition, qualitative

analysis, and method execution, Bruker Diffrac.Suite.EVA® (XRD) - for diffraction pattern analysis, phase identification, and crystalline structure evaluation, Metrohm Tiamo®

(Potentiometric Titration) - for titration method programming, data acquisition, and result interpretation, Malvern Mastersizer® - for particle size analysis, including method development and particle distribution analysis, and UV-Vis software - for ultraviolet-visible spectroscopy data acquisition, qualitative/quantitative analysis, and spectral evaluation

REQUIREMENTS: BS Analytical Chemistry or related

EXPERIENCE: 60 months as an Analytical Chemist, Chemist- Quality Control or related occupation

Salary: $95,000 to 115,000 base salary/year + std company benefits

Job site: 1 Ram Ridge Road, Chestnut Ridge, NY 10977