Brian Rogers
Lenoir,NC
Summary
Dedicated Quality professional with a history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Overview
14
14
years of professional experience
Work History
Senior Manager – QA Compliance
Stallergenes Greer
03.2023 - 07.2024
- Responsible for Quality Assurance oversight and support for all areas/functional units of Stallergenes Greer in accordance with relevant industry standards and guidance (21 CFR Part 210 and 211, Guidance for Industry, PDA)
- Provided strong leadership for a team of QA Specialists with overall responsibility for the Deviation, CAPA, and AQL systems
- Conducted performance evaluations, compensations and hiring to maintain appropriate staffing requirements
- Participated in Regulatory inspections (CBER, CDER, USDA, NCDA) and provided input for audit findings responses, as well as assuming ownership of all resultant CAPAs
- Performed QA Compliance review and approval for the following: Internal Audits, Product Complaints, Change Requests, Deviation Investigations, Corrective/Preventive Actions, Out of Limits/Out of Tolerance investigations Validation protocols/summary reports, Standard Operating Procedures, and other document types as required
Quality Assurance Manager – Ancillary Operations
Stallergenes Greer
06.2017 - 03.2023
- Responsible for Quality Assurance oversight and collaboration with departments/functional areas making up the Ancillary Operations unit, ensuring adherence to quality standards and regulatory guidance
- Provided input and guidance to Quality Assurance representatives within other business units of Stallergenes Greer, supporting and collaborating across functional units
- Deviation investigation, Risk Assessment, and CAPA implementation for the Ancillary Operations unit
- Quality Assurance review, assessment, and approval of various document types across all Stallergenes Greer functional units
- Participated in Regulatory inspections (CBER, CDER, USDA, NCDA) and provided input for response generated to subsequent audit findings, as well as assuming ownership of CAPAs resulting from findings related to the Ancillary Operations unit
- Managed and provided oversight for the Document Control Office (DCO)
Quality Assurance Technical Manager
Stallergenes Greer
06.2016 - 06.2017
- Review and approval of all SOPs, Forms, and Specifications for GMP manufacturing, packaging, labeling, and distribution of finished products
- Collaborated with departmental management/subject matter experts to ensure SOPs were relevant and accurate
- Participated in Regulatory inspections (CBER, CDER, USDA, NCDA) and provided input for responses to audit findings
- Participated in customer audits and supplier qualification audits
- Assisted in Deviation investigations and CAPA implementation
- Managed and provided oversight for the Document Control Office (DCO)
Validation Engineer
Stallergenes Greer
01.2015 - 06.2016
- Independently planned, coordinated, and executed Validation projects to ensure timely completion
- Documented entire Validation process, noting changes or alterations required during the process
- Mentored Validation personnel in techniques, methods and processes
- Authored and provided technical guidance for SOPs and other master documents
- Tracked and provided status updates for Validation activities and projects
- Monitored and reported on test results and performance data to identify areas of opportunity for improvement
- Supported Engineering and Technical Operations in development of critical process parameters
- Acted as Validation SME for deviation investigations
- Analyzed data and made recommendations for improvements in manufacturing processes and equipment
Senior Validation Specialist
Stallergenes Greer
03.2013 - 01.2015
- Authored and executed Process Validation and Equipment Qualification activities (IOPQ), analyzed resultant data, and generated summary reports
- Drafted revisions for Validation-specific SOPs
- Participated in the analysis of data and recommendations for improvements in manufacturing processes and equipment
- Assisted in the provision of technical input during deviation investigations
- Conducted peer-review of Validation protocols and reports
Validation Specialist
Stallergenes Greer
08.2010 - 03.2013
- Executed Process Validation and Equipment Qualification activities (IOPQ), analyzed resultant data, and generated summary reports
- Drafted revisions for Validation-specific SOPs
- Participated in analysis of data and recommendations for improvements in manufacturing processes and equipment
- Participated in peer-review of Validation protocols and reports
Education
Associate of Science - Industrial Engineering
Western Piedmont Community College
Morganton, North CarolinaSkills
- Quality Management
- GMP/GDP
- Understanding of Regulatory Guidance (21 CFR Part 210 and 211, Guidance for Industry, PDA)
- Team Management/Supervision
- Data Analysis
- KPIs
- Deviation Investigation
- Root Cause Analysis
- Corrective/Preventive Action
- Change Control
- Complaint Investigation
- Validation/Qualification Processes
- Troubleshooting and Problem Resolution
- MasterControl QMS
- Cross-Functional Collaboration
- Talent Development
Accomplishments
Certificate with Distinction – INSEAD Developing Emerging Leaders Executive Education Program
Timeline
Senior Manager – QA Compliance
Stallergenes Greer
03.2023 - 07.2024
Quality Assurance Manager – Ancillary Operations
Stallergenes Greer
06.2017 - 03.2023
Quality Assurance Technical Manager
Stallergenes Greer
06.2016 - 06.2017
Validation Engineer
Stallergenes Greer
01.2015 - 06.2016
Senior Validation Specialist
Stallergenes Greer
03.2013 - 01.2015
Validation Specialist
Stallergenes Greer
08.2010 - 03.2013
Associate of Science - Industrial Engineering
Western Piedmont Community College
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