Rhonda Augustus

WORK HISTORY

EDUCATION

SKILLS

ABOUT RHONDA AUGUSTUS

SENIOR QUALITY ASSURANCE PROFESSIONALAreas of Focus: Quality Assurance/Quality Engineering /Complaints Handling and Compliance activities for government-regulated medical device and pharmaceutical manufacturers.QUALIFICATIONS: Expert in all facets of quality assurance, quality engineering, risk management, change control activities. Experienced in complaint handling processing. Conducts risk assessments, device history record reviews, and database reviews for the Complaint Investigation Summary. Methodical, results-driven, and a competent professional with knowledge of diverse laboratory practices and techniques including CAR-T Cell Therapy, Environmental Monitoring, fermentation, oral dosage, aseptic fill, and medical devices. Proven ability to influence and direct cross-functional initiatives. Effective at leading projects in multi-site operations, resolving conflicts, driving efficiencies, streamlining processes, and accomplishing goals in high-pressure environments while maintaining quality, and timeliness. Equipped with excellent communication skills essential in cultivating positive relationships with individuals of various levels and backgrounds.AREAS OF EXPERTISE:Regulatory & Technical Proficiencies:Compliance: Food and Drug Administration (FDA)| 21 CFRs Part 210, 211, and 820| U.S Department of Agriculture (USDA)| ISO 13485| ISO 9001 |ISO 14971 | Canadian Medical Devices Conformity Assessment SystemQuality Assurance: Quality Management Systems | Design History Record Review | Root Cause Analysis | Nonconformance Investigation and Reporting | Deviations |CAPA |Change Management | cGMP Practices | cGMP Environment Auditing | Good Documentation Practices | Quality Control | Good Laboratory Practices | Regulatory Compliance | Complaint Handling | Annual Product Review |Contract Manufacturing| Problem Solving SkillsQuality Engineer: New Product Introduction | Design Control (from Development & Planning through Design Transfer and Design Changes)| Process, Software, and Equipment Validation | Change Requests | Review and approve Design History Files Technical: Project Management | Product Testing Review | Manufacturing (Purification, Cell Processing |Quality Assurance Remediation |Knowledgeable of Veterinary Practices | Laboratory Operations | Customer service with demonstrated ability to work effectively in a cross-functional team environment| CAR-T Cell Therapy| Environmental Monitoring