Quality Assurance Specialist – Pharmaceutical Manufacturing (contract)

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

Title: Quality Assurance Specialist – Pharmaceutical Manufacturing
Location: Swiftwater, PA
Pay Rate: $65.00–$84.00 per hour
Schedule: 1st Shift | Monday–Friday, 8:00 AM–4:30 PM
Contract Duration: 9 Months

Position Overview

Sanofi's contingent workforce program, FLEXT Direct, is seeking an experienced Quality Assurance / Quality Systems Specialist to support pharmaceutical manufacturing operations in Swiftwater, PA.
This opportunity focuses on Deviation Management, Quality Systems, CAPA, Change Control, and Continuous Improvement within GMP-regulated manufacturing operations.
The ideal candidate has hands‑on experience investigating manufacturing quality issues, working with electronic manufacturing systems, and supporting process improvements in a pharmaceutical or biotechnology environment.

Key Responsibilities

• Manage manufacturing deviations, CAPAs, Change Controls, and quality investigations.
• Conduct root cause analysis, troubleshooting, and corrective and preventive action planning.
• Support Quality Systems and Continuous Improvement initiatives within Formulation and Filling operations.
• Partner with Manufacturing, Quality Assurance, Engineering, and technical teams to resolve manufacturing quality issues.
• Utilize electronic manufacturing and Quality Management Systems to document, track, and manage quality activities.
• Identify opportunities to improve manufacturing performance, quality compliance, and operational efficiency.
• Author and maintain accurate GMP documentation, investigations, and technical reports.

Required Qualifications

• Bachelor's degree and 3–5 years of relevant experience.
• Strong experience with deviations, Quality Systems, and continuous improvement in a regulated GMP pharmaceutical or biotechnology manufacturing environment.
• Experience with electronic Batch Records (eBR), Opstrakker, Manufacturing Execution Systems (MES), or comparable digital manufacturing systems.
• Experience with electronic Quality Management Systems (eQMS), such as Qualipso, Veeva, or equivalent platforms.
• Knowledge of cGMP regulations, quality investigations, and manufacturing compliance.
• Strong analytical, documentation, technical writing, and problem-solving skills.
• Ability to work independently and collaborate with cross-functional teams.

Preferred Qualifications

• Direct experience in pharmaceutical or biotechnology manufacturing.
• Experience supporting Formulation, Filling, Lyophilization, or Inspection operations.
• Familiarity with Overall Equipment Effectiveness (OEE) and manufacturing performance metrics.
• Experience with Lean Manufacturing, Six Sigma, or process improvement initiatives.