Data Integrity Scientist – QC Review (Onsite)

Dormont Manufacturing Co; Nouvelle-Calédonie; In loco; EUR 61.376 - 96.449; Tempo pieno

Vantaggi offerti da questo lavoro

Defined career path

Diverse culture

Career growth

PTO & holidays

Community initiatives

Benefits day one

Tuition reimbursement

Descrizione del lavoro

Catalent is seeking a Scientist, Data Review to join our Morrisville, NC team. This role focuses on reviewing and verifying analytical data for raw materials, packaging, in-process, finished product, and stability testing to ensure accuracy, completeness, and compliance with USP, EP, JP, and internal cGMP standards.

The candidate will perform Level 2 data reviews, verify instrument performance, support OOS/OOT investigations, and contribute to CAPA activities while maintaining data integrity

Competenze

• 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 HPLC, GC, FTIR.
• Strong understanding of cGMP, data integrity, and regulatory expectations.
• Proficiency in reviewing data from HPLC, GC, FTIR, UV, and wet chemistry techniques.

Mansioni

• Perform independent Level 2 review of analytical data for materials and products.
• Review test results generated using HPLC, GC, FTIR, UV and wet chemistry per USP/EP/JP and in-house methods.
• Conduct audit trail reviews to ensure data changes are traceable and compliant (ALCOA+).
• Review raw data, calculations, and documentation for accuracy and integrity.
• Verify system suitability, instrument performance, and method compliance during data review.
• Support investigations including OOS, OOT, deviations, and CAPA implementation.
• All other duties as assigned.

Conoscenze

Data review

HPLC

GC

FTIR

cGMP knowledge

Regulatory compliance

Analytical testing

Formazione

Bachelor’s degree in Chemistry/Pharmaceutical Sciences

Master’s degree in Chemistry/Pharmaceutical Sciences

Strumenti

Empower

LIMS

TrackWise

Descrizione del lavoro

Catalent is seeking a Scientist, Data Review to join our Morrisville, NC team. This role focuses on reviewing and verifying analytical data for raw materials, packaging, in-process, finished product, and stability testing to ensure accuracy, completeness, and compliance with USP, EP, JP, and internal cGMP standards.

The candidate will perform Level 2 data reviews, verify instrument performance, support OOS/OOT investigations, and contribute to CAPA activities while maintaining data integrity