GMP Data Review & Compliance Analyst

West Pharmaceutical Services; Exton (PA); Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

Continuous Learning

Generous PTO

Global Career Opportunities

Inclusive Culture

Recognition & Rewards

Volunteerism

Job summary

West Pharmaceutical Services in Exton, PA is seeking a data reviewer to independently audit analytical data for GMP compliance, accuracy, completeness, and regulatory adherence. Familiarity with lab testing practices and data interpretation is required, along with mentoring colleagues as needed.

You will collaborate with Laboratory Services, Project Management, and Quality, review electronic data and audit trails, and maintain proficiency in MS Office and LIMS.

Qualifications

• Bachelor's degree in Chemistry or related field preferred.
• 3+ years of experience in data review, lab, and/or cGMP environment.
• Experience with cGMP data integrity and compliance practices.

Responsibilities

• Perform cGMP Data Review on analytical data including raw materials and finished goods.
• Review data from multiple analytical techniques and lab results.
• Audit Electronic Data and Audit Trails for Data Integrity.
• Support GMP compliance guidance and data integrity initiatives.
• Collaborate with Laboratory Services, Project Management, and Quality.
• Manage projects from Protocol to final report.

Skills

cGMP Data Review

Data interpretation

MS Office proficiency

LIMS

Quality collaboration

Document control

Education

Bachelor's in Chemistry

Tools

Master Control

SAP/ERP

SharePoint

Job description

West Pharmaceutical Services in Exton, PA is seeking a data reviewer to independently audit analytical data for GMP compliance, accuracy, completeness, and regulatory adherence. Familiarity with lab testing practices and data interpretation is required, along with mentoring colleagues as needed.

You will collaborate with Laboratory Services, Project Management, and Quality, review electronic data and audit trails, and maintain proficiency in MS Office and LIMS.