Quality Documentation Specialist – QC & GDP

Sanofi Group; Pennsylvania; On-site; USD 45,000 - 65,000; Full time

Job summary

Sanofi in Swiftwater, PA is seeking a Document Coordinator to support quality systems in Manufacturing & Supply. You will manage QC documentation lifecycle, ensure GDP compliance, and coordinate cross-functional reviews.

The role requires a Bachelor's in Chemistry/related field and 3-5 years in QC labs; strong data integrity, attention to detail, and experience with QualiPSO or similar systems.

Qualifications

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related field.
• 3-5 years of experience in QC laboratory operations; pharma environment preferred.
• Strong understanding of GxP requirements and pharmaceutical quality systems.
• Experience with analytical testing methods and equipment.
• Proficiency in document management systems (QualiPSO, electronic) and data integrity concepts.
• Experience coordinating documentation workflows and stakeholder reviews.
• Excellent attention to detail and organizational skills.
• Strong written and verbal communication skills.
• Knowledge of iShift functionality is preferred.

Responsibilities

• Review test data for accuracy, completeness, and compliance.
• Coordinate creation, review, and approval of QC SOPs and documents.
• Manage document change requests and assess impact on testing operations.
• Maintain document control records and versioning.
• Support regulatory inspections with documentation expertise.
• Train staff on new or revised procedures.

Skills

Attention to detail

Written and verbal communication

Quality systems knowledge

GxP awareness

Analytical testing familiarity

Education

Bachelor's degree in Chemistry/Biology/Pharmaceutical Sciences

Tools

QualiPSO

Electronic document management systems

Job description

Sanofi in Swiftwater, PA is seeking a Document Coordinator to support quality systems in Manufacturing & Supply. You will manage QC documentation lifecycle, ensure GDP compliance, and coordinate cross-functional reviews.

The role requires a Bachelor's in Chemistry/related field and 3-5 years in QC labs; strong data integrity, attention to detail, and experience with QualiPSO or similar systems.