QC Analyst - Data & Documentation Specialist

Sanofi; Pocono Township (PA); On-site; USD 37,000 - 50,000; Full time

Benefits offered by this job

Health benefits

Parental leave (14 weeks)

Wellness programs

Job summary

Sanofi in Swiftwater, PA is seeking a QC Analyst to join the Manufacturing & Supply network. You will review test data, coordinate QC documentation, and support CAPA investigations to ensure cGMP compliance and data integrity.

The role requires a Bachelor's degree in a related field and 3–5 years of QC laboratory experience in a pharmaceutical setting, with proficiency in QualiPSO and documentation workflows.

Qualifications

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

Responsibilities

• Review test data for accuracy, completeness, and compliance
• Coordinate creation, review, and approval of QC SOPs and technical documents
• Manage document change requests and assess impact on testing operations
• Facilitate document review meetings with cross-functional teams
• Maintain document control records and ensure proper version management
• Support regulatory inspections with documentation and technical expertise
• Participate in CAPA investigations related to testing or documentation issues
• Monitor documentation metrics and report on completion status
• Train laboratory personnel on new or revised procedures
• Perform QC data review of executed tests in a timely manner
• Inform manager of quality or HSE events and participate in investigations
• Coordinate quality control documentation lifecycle activities
• Monitor document revision schedules and coordinate periodic reviews
• Liaise with SMEs for document content development
• Coordinate stakeholder reviews and consolidate feedback
• Execute CAPAs related to remediation plans and improvements
• Ensure lab facilities and instruments are in good quality and safety status
• Execute analytical testing in a timely manner
• Record all raw data to comply with data integrity requirements

Skills

QC data review

GxP knowledge

GDP knowledge

Document management

cGMP compliance

Analytical testing methods

Education

Bachelor’s degree in Chemistry/Biology/Pharmaceutical Sciences

Tools

QualiPSO

Electronic document management system

Job description

Sanofi in Swiftwater, PA is seeking a QC Analyst to join the Manufacturing & Supply network. You will review test data, coordinate QC documentation, and support CAPA investigations to ensure cGMP compliance and data integrity.

The role requires a Bachelor's degree in a related field and 3–5 years of QC laboratory experience in a pharmaceutical setting, with proficiency in QualiPSO and documentation workflows.