Eric Roeun

Key Responsibilities

• Applied knowledge of 21 CFR Part 820, 210/211 to maintain regulatory compliance.
• Executed and managed quality records using Veeva Vault with extensive experience in documentation and data integrity.
• Closed deviations and created CAPAS to address root causes and prevent recurrence.
• Performed troubleshooting and root cause analysis to resolve process and quality issues effectively.
• Conducted Gemba walks to identify opportunities for process improvement, increasing value and output in manufacturing operations.
• Investigated excursions and patient starting material issues, reducing turnaround time for record completion.
• Performed routine process investigations and implemented corrective actions to maintain compliance and efficiency.
• In process of achieving Green Belt Certification and Lean Six Sigma principles to optimize workflows.
• Strong knowledge of MES System, KLIM, Oracle EBS, and Bmram systems for managing manufacturing and quality processes.
• Proficient in Microsoft Office and other tools for data analysis and reporting.

Other Responsibilities

• Manage and initiate Quality Records, ensuring timely resolution of issues through cross-functional collaboration.
• Draft clear, precise process comments to support operational excellence.
• Author and lead investigations for major deviations.
• Partner with MTS and collaborate with MSAT, QE, QC, MFG, QA, and Facilities to drive assigned initiatives.
• Implement Human Error Reduction strategies and Right-First-Time initiatives in partnership with Manufacturing.
• Track and analyze Quality Record and Technical Writing team metrics; identify trends and recommend improvements.
• Apply deep knowledge of manufacturing processes, GDP, and cGMP to ensure compliance and efficiency.
• Design and execute CAPAs to address root causes and verify effectiveness.
• Conduct thorough deviation investigations using advanced Root Cause Analysis tools in collaboration.
• Develop and revise SOPs, batch records, technical reports, and other operational documents to maintain accuracy and compliance.
• Ensure timely completion of all mandatory training requirements.
• Maintain gowning certification and Aseptic Operator Qualification as applicable.
• Execute additional tasks and responsibilities as directed by management.

• Updated and maintained Standard Operating Procedures (SOPs) for facilities to ensure compliance and operational efficiency.
• Supported and led audits including NADCAP, AS9100 QMS, AQMD, and Aerospace Customer Audits, ensuring successful outcomes.
• Implement and maintain a robust Quality Management System (QMS), ensuring processes and procedures align with specifications and customer requirements.
• Conduct internal and external audits to verify compliance; certified Internal Auditor.
• Utilize advanced proficiency in Microsoft Word, Excel, PowerPoint, Publisher, and data analysis tools to support quality initiatives.
• Lead the Quality Department and provide cross-functional support to other departments to uphold company-wide compliance.
• Collaborate with colleagues, customers, and suppliers to troubleshoot and resolve quality-related issues promptly.
• Develop, revise, and implement SOPs, work instructions, and forms to strengthen the stability of the QMS.
• Build and maintain strong relationships with customers and vendors to ensure satisfaction and long-term partnerships.
• Apply expertise in RCA, Root Cause Analysis, RAIL, Fishbone, Cause-and-Effect, and 5 Whys methodologies to drive preventive actions.
• Deliver new and refresher training programs to enhance departmental knowledge and compliance.
• Identify and create opportunities for continuous improvement across processes and systems.
• Monitor acceptance and rejection data, prepare reports, and collaborate with departments to meet customer requirements.
• Reduce rejection rates by implementing improved processes, work instructions, and targeted employee training.
• Provide clear timelines, deadlines, and status updates on quality issues during meetings.
• Organize and maintain revision control for company procedures and documentation.
• Develop and track quality metrics to identify gaps and implement corrective measures for system improvement.

• Implement and maintain a robust Quality Management System (QMS) and procedures in alignment with process specifications and customer requirements.
• Conduct internal and external audits to ensure compliance; certified AS9100 Internal Auditor.
• Facilitate customer and third-party audits, ensuring successful outcomes and adherence to standards.
• Leverage advanced proficiency in Microsoft Word, Excel, PowerPoint, Publisher, and data analysis tools to support quality initiatives.
• Manage Continuous Improvement Program to drive effectiveness and support employees in day-to-day implementation of QMS.
• Collaborate with Sales and Marketing teams to enhance revenue; develop and present quality metrics, customer returns, and on-time delivery reports for meetings.
• Partner with customers and suppliers to resolve issues promptly and maintain strong relationships.
• Develop, revise, and implement quality procedures and training plans to foster continual improvement.
• Assist in supervising production workflow to ensure consistent output and operational efficiency.
• Build and maintain strong customer relationships to ensure satisfaction and long-term partnerships.
• Apply problem-solving and multitasking skills to maintain steady workflow and achieve daily goals.
• Provide customers with accurate completion dates and status updates for purchase orders.

• Implement and maintain a robust Quality Management System (QMS) and procedures in alignment with process specifications and customer requirements.
• Conduct internal and external audits to ensure compliance; certified AS9100 Internal Auditor.
• Facilitate customer and third-party audits, ensuring successful outcomes and adherence to standards.
• Utilize advanced proficiency in Microsoft Word, Excel, PowerPoint, Publisher, and data analysis tools to support quality initiatives.
• Manage Continuous Improvement Program to drive effectiveness and support employees in day-to-day implementation of QMS.
• Collaborate with customers and suppliers to resolve issues promptly and maintain strong relationships.
• Develop, revise, and implement quality procedures and training plans to foster continual improvement.
• Ensure chemical processes remain within specification limits and perform testing in compliance with requirements.
• Provide flexible support across multiple roles to maintain operational efficiency and meet organizational goals.