Quality Systems Specialist - Pharmaceutical Manufacturing (contract)

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.

• 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.