Brian Rogers

Work History

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.

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).

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).

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.

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.

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.