GMP Data Integrity & Quality Reviewer

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

Benefits offered by this job

Hybrid work model

Job summary

West Pharmaceutical Services, Inc. is seeking a Specialist, Data Review in Exton, PA, to independently review analytical data for GMP compliance and data integrity. The role requires mentoring others and applying knowledge of laboratory data review and regulatory requirements.

The position is hybrid, onsite at least 3 days per week with no relocation offered. Collaboration with Quality, Laboratory Services, and Project Management is essential to ensure accurate data interpretation and reporting.

Qualifications

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

Responsibilities

• Perform cGMP Data Review on analytical data from various materials and tests.
• Review data from analytical techniques and ensure compliance to procedures.
• Review Electronic Data and Audit Trails for Data Integrity.
• Collaborate with Laboratory Services, Project Management and Quality.
• Maintain knowledge of MS Office, Master Control, LIMS, Empower and LMS.
• Manage projects from Protocol to final report.

Skills

Independent work

Multitasking

Communication

Problem-solving

Interpersonal skills

Team collaboration

Education

Bachelor's degree in Chemistry or related field

Tools

Master Control

SAP/ERP

SharePoint

Microsoft Office

Excel

Word

PowerPoint

Job description

West Pharmaceutical Services, Inc. is seeking a Specialist, Data Review in Exton, PA, to independently review analytical data for GMP compliance and data integrity. The role requires mentoring others and applying knowledge of laboratory data review and regulatory requirements.

The position is hybrid, onsite at least 3 days per week with no relocation offered. Collaboration with Quality, Laboratory Services, and Project Management is essential to ensure accurate data interpretation and reporting.