Senior Compliance Specialist

Senior Compliance Specialist

Requirements

• Associate’s degree in Life Sciences or related field with 6+ years’ experience – required
• Exemplary technical writing skills, experience with deviation investigations and corrective action plans – required
• Advanced computer proficiency
• Strong verbal and written communication skills
• Experience with quality systems
• Experience with cGMP data review
• Adherence to on-time closures for quality metrics
• Advanced technical writing proficiency

Responsibilities

• Assisting Engineering Manager with Deviation Intake and Closure
• GEMBA meetings with cross-functional team
• Major/Critical Deviations – Technical Writing
• Lot Tagging Adherence
• Change Control Steps Completion
• Implement Effectiveness Reviews
• Practices safe work habits and adheres to Sanofi’s safety procedures and guidelines
• Participates in cross-functional teams to drive investigation close-outs, determine root cause and implement appropriate corrective and preventative actions
• Participates on cross functional Continuous Improvement teams with Manufacturing, Validation, Quality, Facilities, Metrology and Maintenance
• Coordinates SME assessments for all CCR’s assigned to the Facilities and Engineering team
• Works under general supervision and direction
• Continuous improvement mindset
• Performs routine documentation assessments to ensure alignment between SOP’s/Standards
• Participates in cross functional projects and performs SME assessments for all CCRs assigned to Engineering
• Effectively demonstrates understanding of GMPs and how it applies to specific responsibilities

Preferred Qualifications

• Bachelor’s degree in Life Sciences or related field with 4+ years’ experience – preferred
• Experience with deviations and CAPA events in a manufacturing operations setting – preferred
• Experience in cGXP manufacturing environment
• Experience in troubleshooting, investigating, and root cause analysis in a GXP environment