Quality Assurance Specialist – Pharmaceutical Manufacturing (contract)

Sanofi

Swiftwater, PA

Pay: $65-$84/hr

Shift: Contract

**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.