QC Analyst: Quality Data & Documentation Specialist

BioSpace; Swiftwater (Monroe County); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health benefits

Parental leave (14 weeks)

Wellbeing programs

Competitive rewards

Job summary

Sanofi US Services in Swiftwater, PA is seeking a QC Analyst to support analytical testing, data review, and quality documentation in a cGMP environment. You will ensure GDP practices, maintain QC documents, and participate in CAPA investigations alongside cross-functional teams.

The role requires a Bachelor's degree in a related field and 3–5 years in QC lab operations, preferably in pharma, with strong data integrity and documentation skills.

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/or pharmaceutical quality systems.
• Experience with analytical testing methods and equipment.
• Proficiency in document management systems (e.g., QualiPSO, electronic document management systems).
• 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.

Responsibilities

• Ensuring qualified personnel perform assigned analytical testing.
• Perform QC data review of executed tests in a timely manner.
• Inform manager of quality or HSE deviations and participate in investigations.
• Support root cause analysis for testing deviations.
• Coordinate quality control documentation lifecycle activities.
• Manage document workflows with review, approval, and distribution processes.
• Ensure GDP-compliant documentation.
• Create, maintain, and update QC documentation and SOPs.
• Monitor revision schedules and coordinate periodic reviews.
• Liaise with SMEs for content development and metadata management.

Skills

Attention to detail

Organizational skills

Written and verbal communication

GxP knowledge

Education

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

Tools

QualiPSO

Job description

Sanofi US Services in Swiftwater, PA is seeking a QC Analyst to support analytical testing, data review, and quality documentation in a cGMP environment. You will ensure GDP practices, maintain QC documents, and participate in CAPA investigations alongside cross-functional teams.

The role requires a Bachelor's degree in a related field and 3–5 years in QC lab operations, preferably in pharma, with strong data integrity and documentation skills.