Sheira Summerour
Gainesville,GA
Summary
Dynamic Quality & Regulatory Coordinator at Currahee Group with expertise in regulatory compliance and continuous improvement. Proven track record in leading audits and implementing corrective actions, enhancing product quality and safety. Strong communicator with exceptional document management skills, ensuring adherence to GMP standards and fostering cross-functional collaboration.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Quality & Regulatory Coordinator
Currahee Group
03.2025 - Current
- Assisted in maintaining regulatory compliance by organizing documentation and tracking submissions.
- Supported preparation of regulatory filings, ensuring accuracy and timeliness of information.
- Conducted research on regulatory requirements to assist team in understanding industry standards.
- Collaborated with cross-functional teams to gather necessary information for compliance activities.
- Monitored changes in regulations to update internal processes and procedures accordingly.
- Monitored quality of product.
- Investigate quality defects, find root cause for said defects and implemented corrective action(s).
- Creating processes, make improvements to existing processes as part of GMP standards.
- Investigate customer quality complaints, find root cause, implement corrective action(s), and report findings to plant manager, CSR, as well as to the customer.
- Prepare for and lead 3rd party audits.
- Lead continuous improvement efforts.
- Maintain Quality Manual, revise when needed.
- Responsible for two facilities: Spectrum Packaging Network in Marietta, GA. Pak-Pro in Toccoa, Ga.
Quality Assurance Technician
Packaging Specialties Inc of Georgia
02.2017 - 01.2021
- Conducted quality inspections to ensure compliance with industry standards.
- Assisted in documenting non-conformities and initiating corrective actions.
- Performed routine testing on products to verify functionality and safety.
- Collaborated with production teams to address quality-related issues promptly.
- Utilized inspection tools and software for accurate data collection and reporting.
- Maintained cleanliness and organization of testing environments to uphold safety standards.
- Supported audits by providing necessary documentation and product samples.
- Engaged in continuous learning of quality assurance methodologies and best practices.
- Conducted root cause analyses for identified defects, implementing preventive measures to minimize recurrence rates.
- Performed thorough inspections of incoming materials and outgoing products.
- Contributed to continuous improvement initiatives by actively participating in regular team meetings and sharing insights about potential areas of improvement.
- Inspected finished products for overall quality and adherence to GMP, BRC specifications.
- Maintained accurate documentation of all quality-related activities, facilitating easy access to records when needed.
- Collaborated with cross-functional teams to develop comprehensive quality control strategies, ensuring optimal product performance.
- Increased overall product reliability through diligent monitoring of equipment calibration and maintenance schedules.
- Evaluated samples against standards by completing measurements, visual inspections, and other established tests.
- Maintained inventory for Production and Maintenance.
- Procurement for Quality Assurance, Production and Maintenance departments.
Logistics Specialist
Kubota Manufacturing of America
05.2013 - 08.2016
- Coordinated logistics operations to ensure timely delivery of goods across multiple buildings and or locations
- Implemented inventory management systems, reducing discrepancies and improving accuracy.
- Trained junior staff on best practices in logistics procedures and software usage.
- Managed inventory levels for minimal stockouts.
- Handled high-volume paperwork and collaborated with administrators to resolve process failures.
- Performed warehouse audits, ensuring accuracy and that processes were being followed.
- Created part locations for production line based on analysis and lean manufacturing standards.
Injection Molding Machine Operator
NOK
08.2007 - 01.2011
- Operated injection molding machines to produce high-quality plastic components efficiently.
- Monitored production processes, ensuring compliance with safety standards and quality specifications.
- Adjusted machine settings based on product requirements, optimizing production cycles for efficiency.
- Trained new operators on safe machine operation and best practices in injection molding processes.
Education
High School Diploma -
Cross Keys
Atlanta, Georgia Skills
- Document control
- Regulatory submissions
- Global regulatory compliance
- Regulatory policies
- Document management
- Regulatory agency applications
- Audits
- ISO standards
- Inspections
- International regulations
- Requests for information
- Product information
- Product inspection
- Visual inspection
- Equipment calibration
- Inspections and reviews
- Documentation skills
- Auditing techniques
- Continuous improvement
- Product sampling
- Software applications
- Testing procedures
- Customer focus
- Quality management systems
- Compliance verification
- Lean manufacturing
- GMP auditing
- Quality auditing
- Raw materials testing
- Quality issue identification
- Attentive and observant
- Data entry
- Safety compliance
- Materials testing
- Documentation
- Product Inspections
- Safety procedures
- Finished goods inspection
- Testing documentation
- Materials inspections
- Corrective actions
- Raw materials receiving
- Audit assistance
- Corrective action implementation
- Quality sops development
- Excellent communication
- Production monitoring and assessment
- Operations monitoring
- QMS
Certification
AIB Food Defense Coordinator
Timeline
Quality & Regulatory Coordinator
Currahee Group
03.2025 - Current
Quality Assurance Technician
Packaging Specialties Inc of Georgia
02.2017 - 01.2021
Logistics Specialist
Kubota Manufacturing of America
05.2013 - 08.2016
Injection Molding Machine Operator
NOK
08.2007 - 01.2011
High School Diploma -
Cross Keys