GxP QC Analyst: Data & Documentation Lead

Sanofi; Northern (KY); Hybrid; USD 37,000 - 50,000; Full time

Job summary

Sanofi in Swiftwater, PA is seeking a QC Analyst to join the Manufacturing & Supply organization. The role emphasizes test data review, QC data review, and maintaining GDP-compliant documentation while supporting investigations and CAPAs.

Ideal candidates hold a Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences or related field with 3–5 years of QC lab experience in a pharmaceutical setting, knowledge of GxP, and experience with document management systems such as QualiPSO.

Qualifications

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences or related field.
• 3–5 years of experience in QC laboratory operations in a pharmaceutical environment preferred.
• Strong understanding of GxP requirements and data integrity principles.

Responsibilities

• Review test data for accuracy, completeness, and compliance.
• Perform QC data review of executed tests in a timely manner.
• Coordinate quality control documentation lifecycle and GDP-compliant docs.
• Support CAPA investigations related to testing or documentation issues.

Skills

Attention to detail

Organizational skills

Communication skills

Education

Bachelor's degree in Chemistry/Biology/Pharmaceutical Sciences

Tools

QualiPSO

Job description

Sanofi in Swiftwater, PA is seeking a QC Analyst to join the Manufacturing & Supply organization. The role emphasizes test data review, QC data review, and maintaining GDP-compliant documentation while supporting investigations and CAPAs.

Ideal candidates hold a Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences or related field with 3–5 years of QC lab experience in a pharmaceutical setting, knowledge of GxP, and experience with document management systems such as QualiPSO.