Sommer Warren
Irmo
Summary
Dedicated and strategic quality assurance specialist with 10+ years of QA/QC and Customer Service experience. Possess expertise in compliance standards, HACCP, GMPs and customer service. Promoted industry best practices career-long. Highly adept at developing, training, and supervising teams to peak-performance.
Professional with strong background in customer interactions and service solutions. Highly skilled in conflict resolution, communication, and problem-solving, ensuring customer satisfaction and loyalty. Effective team collaborator, adaptable to changing needs, and consistently focused on achieving results through efficient and empathetic service. Known for reliability and proactive approach to meeting customer and organizational goals.
Overview
23
23
years of professional experience
1
1
Certification
Work History
Quality Assurance Technician
Keurig Dr Pepper, Inc.
Moore, SC
02.2025 - Current
- Conducted thorough inspections of products to ensure compliance with quality standards.
- Implemented corrective actions for non-conforming products to enhance quality control measures.
- Collaborated with production teams to address quality issues and improve operational efficiency.
- Analyzed quality data and trends to identify areas for continuous improvement initiatives.
QA/QC AND CUSTOMER SERVICE SPECIALIST
Ortho Technology
West Columbia, SC
01.2012 - Current
- Tracked and conducted multiple testing on components, complaints, finished products, and materials to ensure orders were completed according to client specifications.
- Providing high-quality customer service to our customers that submit a complaint. Review DHR’s when applicable.
- Answering phones, problem solving
- Preserved product quality by ensuring compliance to FDA regulations, manufacturing best practices, client specifications, and ISO standards.
- Followed-up on preventative measures to ensure solutions were completed and correct. Calibrated and performed minor maintenance of laboratory instruments.
- Saved company thousands of dollars by reverifying procedure and adding verification checks due to large quantity of product placed on quality hold.
- Generated and submitted required reports, including reviewing and verifying quality assurance paperwork and documentation. Provided ISO with needed documentation.
- Investigation customer complaints
- Enhanced staff development and performance by training personnel on correct housekeeping practices, GMPs, and SSOPs to perform stability and capability testing to ensure product integrity.
- Ensured operational compliance to ISO standards by participating in GMP walkthrough audits.
- Supports Regulatory Affairs in their effort to achieve and sustain compliance with regulatory standards, including FDA and European requirements.
- Create/draft, update and review Standard Operating Procedures (SOPs)
- Assist with regulatory audits and inspections.
- Support the Quality Manager in efforts to conduct periodic trend analysis and provides business impact analysis of product and process to monitor and develop appropriate corrective/preventive actions to ensure product quality, patient safety and compliance with regulatory reporting requirements.
- Maintain knowledge of relevant quality and regulatory standards and augment quality system processes to meet changing requirements, including the MDR, FDA, MDSAP and others as required.
- Deviations and Nonconformances: Review, approve and monitor the events and deviations. Complaint handling and investigations Track and facilitate investigation in cross functional team discussions in support of closing Quality Events
- Compliance: Audit plan and reporting to applicable standards. Review and approval of corrective action and supporting evidence. Aid in audit hosting and preparation. aid in tracking and trending of internal and external findings, investigation and implementation of corrective/ preventive measures.
- Supply/ Vendor Management: Supplier qualification, reassessment activities, quality agreements, quality score cards. Oversee the process is maintained and approved according to processes
- Initiate NCRs/NCMRs documenting non-conformance products as they arise.
- Conduct incoming product inspections as required and review/approve labels for accuracy prior to placement into inventory.
- Receive, inspect, and process customer returns (RMAs) determining appropriate disposition.
- Perform inspections on stock inventory (as required by Quality Management) prior to replacement products being pulled.
- Initiate, create and maintain CIS (Component Inspection Standards) and FAI (First Article Inspections).
- Work with inventory control personnel on product transfer in the ERP system.
- Train warehouse personnel on quality functions, as required.
- A subsidiary of Henry Schein, Inc.
PRODUCTION SUPERVISOR
TYSON FOODS
Council Bluffs, IA
01.2003 - 01.2011
- Developed team from within, recommending employees for raises and preparing associates for increasing responsibility.
- Achieved and maintained departmental, plant, and company goals for safety and quality.
- Managed personnel needs, including setting schedules and tracking time for accurate payroll.
- Met production targets through organized schedules and careful management of priorities.
- Empowered employees to independently solve line problems and keep production running.
- Supervisor different areas throughout the plant.
- Filling out paperwork and staying in compliance with USDA standards
Education
Associate Degree - Business
Midlands Technical College
West Columbia, SCSkills
- Complaint resolution
- Inbound/Outbound calls
- Critical/logical thinking
- Communication skills
- Customer Service
- Device History Record Review (DHR)
- Medical Device
- Forklift
- Product Complaint investigation
- ISO Standards
- Change Control
- Corrective and Preventive Action (CAPA)
- Document Control
- Decision-Making
- Standard Operating Procedure (SOP)
- Problem solving
- Testing procedures
- Documentation skills
- Root-cause analysis
- Shipment inspection
- Line checking
- Functional testing
- Customer focus
- Production line observation
- Quality assurance
Certification
- QMS Training for Medical Devices: FDA QSR and ISO 13485:2016
- Certified Quality Process Analyst Training
- FDA inspections and Data Webinar
CORE COMPETENCIES
- Quality Assurance & Testing
- Medical Device
- Manufacturing Best Practices
- Problem Resolution
- Process Improvement
- Cost Containment
- Compliance
- Strategic Planning
- Documentation & Report Generation
- Staff Development
- Training & Customer Service
- Supervision
- Relationship Management
- Customer Service
Languages
English
Timeline
Quality Assurance Technician
Keurig Dr Pepper, Inc.
02.2025 - Current
QA/QC AND CUSTOMER SERVICE SPECIALIST
Ortho Technology
01.2012 - Current
PRODUCTION SUPERVISOR
TYSON FOODS
01.2003 - 01.2011
Associate Degree - Business
Midlands Technical College