GMP Data Integrity & Review Specialist (Onsite 3x/Week)

West Pharmaceutical Services; Exton (PA); Hybrid; USD 70,000 - 100,000; Full time

Benefits offered by this job

PTO (paid time off)

Global career opportunities

Continuous learning & development

Job summary

West Pharmaceutical Services is seeking a hybrid- onsite (minimum 3 days/week) Data Reviewer to independently review analytical data for GMP compliance, accuracy, and completeness. The role also involves mentoring others and ensuring data integrity across laboratory operations. Requirements include a B.S.

in Chemistry or a related field and 3+ years in a cGMP environment. The candidate will work with MS Office, Master Control, LIMS, Empower, and SAP/ERP systems to support QA and regulatory

Qualifications

• 3+ years of experience in data review, laboratory, and/or cGMP environment.
• Experience with reviewing analytical data and ensuring GMP compliance.
• Familiarity with cGMP regulatory requirements.

Responsibilities

• Review analytical data for cGMP compliance and data integrity.
• Assess data from analytical techniques (CCI, USP/EP/JP, ISO testing, etc.).
• Review electronic data and audit trails for data integrity.
• Manage projects from protocol to final report.
• Collaborate with QA, Laboratory Services, and Project Management.

Skills

Independent work

Multitasking

Communication

Problem solving

Interpersonal skills

Windows OS proficiency

MS Office

Education

Bachelor's degree in Chemistry or related scientific field

Tools

Master Control

SAP/ERP

SharePoint

Job description

West Pharmaceutical Services is seeking a hybrid- onsite (minimum 3 days/week) Data Reviewer to independently review analytical data for GMP compliance, accuracy, and completeness. The role also involves mentoring others and ensuring data integrity across laboratory operations. Requirements include a B.S.

in Chemistry or a related field and 3+ years in a cGMP environment. The candidate will work with MS Office, Master Control, LIMS, Empower, and SAP/ERP systems to support QA and regulatory