GMP Data Review Specialist — Hybrid Quality Role

West Pharmaceutical Services, Inc; Exton (PA); Hybrid; USD 70,000 - 90,000; Full time

Benefits offered by this job

PTO (flexible) stated as generous PTO

Tuition assistance

Leadership development

Bonuses

Global opportunities

Job summary

West Pharmaceutical Services, Inc in Exton, PA is seeking a Data Review Specialist to independently review analytical data for GMP compliance and accuracy. This role requires familiarity with laboratory data review and analytical techniques, and mentorship to others as needed.

Responsibilities include evaluating cGMP data, reviewing audit trails, and collaborating with Laboratory Services, Project Management and Quality to ensure data integrity and regulatory compliance.

Qualifications

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

Responsibilities

• Perform cGMP data review of analytical data generated in GMP environment.
• Review data from analytical techniques and ensure accuracy and compliance.
• Review electronic data and audit trails for Data Integrity.
• Manage projects from Protocol to final report.
• Collaborate with Laboratory Services, Project Management and Quality.

Skills

Data review

cGMP

Data integrity

MS Office

Master Control

LIMS

Empower

SAP/ERP

SharePoint

Education

Chemistry degree

Tools

Master Control

SAP/ERP

SharePoint

Job description

West Pharmaceutical Services, Inc in Exton, PA is seeking a Data Review Specialist to independently review analytical data for GMP compliance and accuracy. This role requires familiarity with laboratory data review and analytical techniques, and mentorship to others as needed.

Responsibilities include evaluating cGMP data, reviewing audit trails, and collaborating with Laboratory Services, Project Management and Quality to ensure data integrity and regulatory compliance.