GMP Data Review & Integrity Analyst

Xtalks

Exton (PA)

Hybrid

USD 75,000 - 110,000

Full time

32 hours ago
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Benefits offered by this job

Generous PTO
Tuition assistance
Continuous learning & development
Global career opportunities
Inclusive culture
Performance bonuses

Job summary

West Pharmaceutical Services seeks a qualified professional to independently review analytical data for GMP compliance, ensuring accuracy and adherence to procedures. The role requires familiarity with lab data review and interpretation of analytical results, with potential mentorship responsibilities.

The candidate will collaborate across Laboratory Services, Project Management and Quality, supporting data integrity initiatives and maintaining expertise in MS Office, Master Control, LIMS,

Qualifications

  • Bachelor's degree in Chemistry or related field required.
  • 3+ years of data review, laboratory, and/or cGMP experience.
  • Experience reviewing analytical data for GMP compliance and data integrity.

Responsibilities

  • Perform cGMP Data Review on analytical data generated in the lab, including materials, products, and testing.
  • Review data from techniques such as CCI testing, ISO/EP/JP testing, ICP, DSC, TGA, IR, UV, AA.
  • Review electronic data and audit trails for Data Integrity compliance.
  • Support GMP compliance guidance and data integrity initiatives.
  • Collaborate with Laboratory Services, Project Management, and Quality.
  • Maintain knowledge of software tools (MS Office, Master Control, LIMS, Empower).
  • Review client reports for cGMP compliance and data integrity.
  • Manage projects from Protocol to final report.

Skills

Data review & interpretation
Independent worker
Communication skills
Regulatory compliance

Education

Bachelor's degree in Chemistry or related field

Tools

MS Office
MasterControl
LIMS
Empower
SAP/ERP
SharePoint

Job description

West Pharmaceutical Services seeks a qualified professional to independently review analytical data for GMP compliance, ensuring accuracy and adherence to procedures. The role requires familiarity with lab data review and interpretation of analytical results, with potential mentorship responsibilities.

The candidate will collaborate across Laboratory Services, Project Management and Quality, supporting data integrity initiatives and maintaining expertise in MS Office, Master Control, LIMS,

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