Quality Data Reviewer – cGMP & Batch Release (2nd Shift)

West Pharmaceutical Services, Inc; United States; On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Generous PTO

Bonuses

Global career opportunities

Job summary

West Pharmaceutical Services, Inc. is seeking a Lab Operations Data Reviewer on 2nd shift to independently analyze data generated for internal and external customers and support post-production QA activities, including finished batch release, sterilization, packaging specifics, and device history documentation.

The role requires knowledge of current regulations, familiarity with SAP, LIMS, and MasterControl, and the ability to work with cross-functional teams.

Qualifications

• No minimum work experience required.
• 1+ year in cGMP environment utilizing SAP preferred.

Responsibilities

• Perform cGMP Data Review on analytical data from Lab Operations.
• Review data per methods, protocols, and Work Instructions for compliance.
• Review Electronic Data and Audit Trails for data integrity.
• Review batch release documentation and Certificate of Compliance.
• Initiate SAP steps related to batch release and sterilization processes.

Skills

cGMP Data Review

SAP

LIMS

Data Integrity

Education

High school diploma or GED

Tools

MS Office

MasterControl

Laboratory Information Systems

Job description

West Pharmaceutical Services, Inc. is seeking a Lab Operations Data Reviewer on 2nd shift to independently analyze data generated for internal and external customers and support post-production QA activities, including finished batch release, sterilization, packaging specifics, and device history documentation.

The role requires knowledge of current regulations, familiarity with SAP, LIMS, and MasterControl, and the ability to work with cross-functional teams.