> Markdown version of [/jobs/ext/4442518-quality-systems-specialist-pharmaceutical-manufacturing-contract](https://www.wearedevelopers.com/jobs/ext/4442518-quality-systems-specialist-pharmaceutical-manufacturing-contract). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md).

---

# Quality Systems Specialist - Pharmaceutical Manufacturing (contract)

- **Company:** Sanofi
- **Location:** Swiftwater, PA, United States
- **Experience:** Experienced
- **Salary:** $135,200.0 - $174,720.0
- **Contract:** Temporary contract
- **Skills:** Microsoft Word, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Visual Systems, Veeva
- **Published:** October 31, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=68d8e8e96f92cbc3

## About the Role

* Bachelor's degree required, preferably in Engineering, Life Sciences, Pharmaceutical Sciences, or a related discipline.
 * 3-5 years of relevant experience in pharmaceutical or biotechnology manufacturing, Quality Systems, Continuous Improvement, or a related regulated GMP environment.
 * Strong experience managing deviations, CAPAs, Change Controls, quality investigations, and root cause analysis.
 * Strong knowledge of cGMP regulations, Quality Systems, and manufacturing compliance requirements.
 * Experience with electronic Batch Records (eBR), Opstrakker, Manufacturing Execution Systems (MES), or comparable digital manufacturing systems.
 * Experience utilizing Quality Management Systems such as Qualipso, Veeva, or equivalent platforms.
 * Knowledge of Lean Manufacturing, Six Sigma methodologies, and continuous improvement principles.
 * Ability to author technical reports, investigations, CAPAs, Change Controls, and related GMP documentation.
 * Strong technical writing, analytical, problem-solving, and project management skills.
 * Excellent communication and interpersonal skills with the ability to lead and influence cross-functional teams.
 * Proficiency with Microsoft Office, including Excel, Word, and PowerPoint., * Direct experience within pharmaceutical or biotechnology manufacturing operations.
 * Experience supporting Formulation, Filling, Lyophilization, or Inspection processes.
 * Familiarity with Overall Equipment Effectiveness (OEE) and utilizing performance metrics to drive equipment and process improvements.
 * Experience with iShift, Qualipso, eBR, or Opstrakker systems.
 * Experience supporting manufacturing process optimization and cross-functional continuous improvement initiatives.

## Description

Sanofi's contingent workforce program, FLEXT Direct, is seeking a Quality Systems Specialist - Pharmaceutical Manufacturing for a 9-month contract opportunity in Swiftwater, PA.

This position will provide dedicated Quality Systems (QS) and Continuous Improvement (CI) support within the Formulation and Filling areas. The contractor will support cross-functional initiatives focused on CAPA, Change Control, quality investigations, manufacturing process improvements, operational excellence, and cGMP compliance., * Serve as an individual contributor on cross-functional teams supporting Production Control Units (PCUs), with emphasis on Formulation and Filling operations.

 * Act as the CAPA and Change Control point of contact for the Formulation and Filling Improvement Program (FFIP).
 * Independently manage CAPA and Change Control action items, author supporting documentation, and ensure timely closure of deliverables.
 * Lead quality investigations, troubleshooting, root cause analysis, product impact assessments, and corrective and preventive actions.
 * Collaborate with Operations, Quality Assurance, Quality Control, MSAT, Sterility Assurance, and Engineering to resolve technical and quality-related issues.
 * Provide technical support for component qualification, Overall Equipment Effectiveness (OEE) improvements, electronic Batch Records (eBR), Opstrakker utilization, and manufacturing improvement initiatives.
 * Lead cross-functional meetings, facilitate issue resolution, and manage multiple projects and competing priorities.
 * Monitor and communicate key performance metrics, utilizing +QDCI Visual Management Systems to drive operational excellence and continuous improvement.
 * Apply Lean Manufacturing and Six Sigma principles to identify and implement process improvements.
 * Ensure compliance with cGMP regulations, Good Documentation Practices (GDP), and applicable regulatory requirements.
 * Support regulatory inspections and audits as required.