Quality Documentation Coordinator

Sanofi Group; Swiftwater (Monroe County); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

14 weeks parental leave

Health and wellbeing benefits

Career growth opportunities

Job summary

Sanofi Group in Swiftwater, PA is seeking a Document Coordinator to join the Manufacturing & Supply team. You will manage QC documentation lifecycle, ensure GDP-compliant processes, and coordinate reviews across cross-functional SMEs to keep documentation accurate and up to date.

You will perform QC data reviews, support investigations and CAPAs related to testing, and help maintain quality systems such as QualiPSO. Strong attention to detail and communication skills are essential.

Qualifications

• Bachelor's degree in Chemistry, Biology, pharmaceutical sciences, or related field.
• 3–5 years of experience in QC laboratory operations.
• Understanding of GxP requirements and/or pharmaceutical quality systems.
• Experience with analytical testing methods and equipment.
• Proficiency in document management systems.

Responsibilities

• QC data review of executed tests to ensure accuracy and timeliness.
• Coordinate quality control documentation lifecycle and reviews.
• Ensure GDP-compliant documentation practices and SOPs.
• Create, maintain, and update QC documents and SOPs.
• Monitor document revision schedules and coordinate periodic reviews.
• Liaise with SMEs for document content development and validation.
• Support metadata management and documentation control in quality systems.
• Coordinate stakeholder reviews and consolidate feedback.
• Executing CAPAs related to remediation plans and testing investigations.

Skills

QC operations

GxP knowledge

Analytical testing methods

Document management systems

Test data review

Stakeholder reviews

Attention to detail

Communication skills

iShift knowledge

Education

Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related field

Tools

QualiPSO

Job description

Sanofi Group in Swiftwater, PA is seeking a Document Coordinator to join the Manufacturing & Supply team. You will manage QC documentation lifecycle, ensure GDP-compliant processes, and coordinate reviews across cross-functional SMEs to keep documentation accurate and up to date.

You will perform QC data reviews, support investigations and CAPAs related to testing, and help maintain quality systems such as QualiPSO. Strong attention to detail and communication skills are essential.