Pharma QA Specialist – Deviation & CAPA Focus

Sanofi; Swiftwater (Monroe County); On-site; USD 90,000 - 116,000; Full time

Job summary

Sanofi in Swiftwater, PA is seeking a Quality Assurance / Quality Systems Specialist to support pharmaceutical manufacturing operations on a 9‑month contract. The role focuses on deviation management, CAPA, change control, and continuous improvement within GMP environments.

The ideal candidate will have hands-on experience investigating manufacturing quality issues, working with electronic manufacturing systems (eBR, MES, eQMS), and collaborating with cross‑functional teams to strengthen

Qualifications

• Bachelor's degree and 3–5 years of relevant GMP experience.
• Experience with deviations, quality systems, and continuous improvement.
• Knowledge of cGMP regulations and manufacturing compliance.
• Strong analytical, documentation, and technical writing skills.
• Ability to work independently and with cross-functional teams.

Responsibilities

• Manage deviations, CAPAs, change controls, and investigations.
• Conduct root cause analysis and corrective actions.
• Support Quality Systems and CI in Formulation and Filling.
• Collaborate with Manufacturing, QA, Engineering and teams.
• Use eBR, MES and QMS to document and track activities.
• Identify opportunities to improve performance and compliance.
• Author GMP documents and technical reports.

Skills

Quality Assurance

GMP compliance

Root cause analysis

Documentation

Problem solving

Education

Bachelor's degree

Tools

MES (Manufacturing Execution Systems)

eBR

eQMS (Qualipso/Veeva)

Job description

Sanofi in Swiftwater, PA is seeking a Quality Assurance / Quality Systems Specialist to support pharmaceutical manufacturing operations on a 9‑month contract. The role focuses on deviation management, CAPA, change control, and continuous improvement within GMP environments.

The ideal candidate will have hands-on experience investigating manufacturing quality issues, working with electronic manufacturing systems (eBR, MES, eQMS), and collaborating with cross‑functional teams to strengthen