Gabriela Graham

Quality Management System Administrator

• Partnered with process owners and authors to develop lean, clear, and compliant SOPs, Work Instructions, Standard Procedures.
• Managed document control processes to ensure compliance with industry standards and regulatory requirements.
• Collaborated with cross-functional teams to streamline documentation workflows and enhance operational efficiency.
• Led Internal GMPs Audits to ensure compliance.
• Participated and Supported of the annual ISO 22716:2007 Audit
• Participated and Supported during FDA surveillance
• Conducted and documented investigations for planned and non planned nonconformances, CAPAs, and change controls, ensuring timely closure and cross-functional alignment.
• Demonstrated strong analytical and problem-solving skills to support continuous improvement initiatives.

Training Coordinator:

• Owned and managed the company-wide Training Management Program (250 employees), including managing and delivering onboarding training, development of training materials, assignment of documentation-based requirements, and monthly compliance reporting.

New Product Development collaboration

• Collaborated with R&D, Operations, Marketing, and Supply Chain in New Product Development (NPD) meetings to facilitate successful product launches.
• Reviewed and approved graphic processes to ensure regulatory and quality alignment.
• Coordinated with external vendors to ensure timely delivery of essential documentation during critical project phases.

Customer Service

• Led customer complaint, adverse events investigations, identifying root causes and coordinating corrective actions with relevant teams.
• Reviewed and tracked KPIs to measure customer satisfaction.

Technology & Systems Integration

• Supported IT in validating and implementing Microsoft Business Central, ensuring system functionality aligned with operational and quality requirements.

Professional Development

• Earned Lean Six Sigma Green Belt certification, applying process improvement methodologies to enhance efficiency and reduce waste.
• Cross-trained for Quality Engineering and Packing Engineering

• Documenting and Reporting Product Quality levels
• Trained Quality Assurance team members on functions to ensure compliance and quality standards.
• Maintained internal label control system to ensure accurate product identification and compliance.
• Training other Quality Assurance members for the proper performance of functions.
• Assisted in laboratory by calibrating and maintaining equipment to uphold testing integrity.
• Assisting in the laboratory, calibrating and maintaining Equipment
• Conducted verification of allergy cleanups to ensure safety compliance.
• Identified, documented, and tracked defects using industry-standard testing tools.
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• Preparation of documents such as correspondence, drafts, memos, and emails
• Managed office supply inventory and purchasing within established budget
• Greeted visitors, directed to appropriate personnel, scheduled appointments as needed
• Ensured confidentiality by handling sensitive issues with discretion
• Managed classification and archiving of documents to enhance administrative efficiency

• Development and implementation of Standard Operating Procedures (SOP's) for products, and processes.
• Reviewed and updated procedures and specifications for in-process and final product to ensure compliance with quality standards.
• Developed flow diagrams and training materials to facilitate onboarding and enhance understanding for new hires and existing personnel.
• Sampling water, raw material, intermediate product, and final product for quality insurance.
• Established relationships with suppliers of sanitizers and cleaning products to maintain consistent inventory.
• Conducted regular audits to verify adherence to Good Manufacturing Practices (GMP) and uphold quality assurance standards.
• Development flow diagrams and training material for new hires and personnel of the company.
• Dealing directly with suppliers of sanitizers and cleaning products.
• Development of Standardized Sanitation Operating Procedures for the Sanitization Department.
• Conducted thorough audits of manufacturing processes to identify areas for improvement.