Terrence Busby Jr.
Quality Specialist
Laurel,MD
Summary
Operations and quality professional with over 6 years of experience in GMP pharmaceutical manufacturing and aseptic operations. Expertise in equipment qualification, deviation management, and CAPA implementation. Proven ability to lead cross-functional teams and enhance processes in contract manufacturing settings. Experienced in training personnel and ensuring product accuracy through rigorous quality management practices.
Overview
7
7
years of professional experience
7
7
years of post-secondary education
Work History
Quality Assurance Specialist
Bora Pharmaceutical Injectables Inc. (fka Emergent BioSolutions Inc.)
07.2024 - Current
- Ensure GMP compliance for aseptic and fill-finish operations, aligning with FDA and cGMP standards.
- Collaborate with Manufacturing, QA, and Engineering to resolve Class 100 cleanroom equipment and process issues.
- Manage QMS records (CAPAs, Change Controls, Deviations) for timely batch disposition and audits.
Quality Assurance Specialist I
Bora Pharmaceutical Injectables Inc. (fka Emergent BioSolutions Inc.)
07.2023 - 07.2024
- Oversaw validation and qualification of fill-finish equipment, ensuring SOP and batch record compliance.
- Partnered with teams on vial filling, labeling, and visual inspection of biologics.
- Conducted investigations, developed CAPAs, and coordinated cross-functional reviews.
Quality Engineer, Analyst III
Bora Pharmaceutical Injectables Inc. (fka Emergent BioSolutions Inc.)
11.2021 - 07.2023
- Led equipment-related investigations, root cause analysis, and technical reporting.
- Implemented process improvements to reduce nonconformance events and streamline documentation.
Lead Bioprocess Associate
Bora Pharmaceutical Injectables Inc. (fka Emergent BioSolutions Inc.)
09.2018 - 11.2021
- Executed aseptic vial filling and automated visual inspections for biologics in Class 100 cleanrooms.
- Trained and mentored staff on aseptic techniques, gowning, and equipment use.
Education
Master of Science - Biotechonology Management
University of Maryland Global Campus
Hyattsville, MD 09.2022 - Current
Bachelor of Science - Biology
Howard University
Washington, DC 09.2013 - 05.2017
Skills
- GMP fill-finish operations
- CAPA and quality audits
- Root cause analysis
- Lean and Six Sigma
- 5S and Kaizen
- Process improvement
- DOE and FMEA
- ISO 9001 compliance
- TQM principles
- LIMS proficiency
- Statistical sampling techniques
- Visual inspection methods
- Cross-functional leadership
- Client-facing communication skills
- Batch Disposition
Timeline
Quality Assurance Specialist
Bora Pharmaceutical Injectables Inc. (fka Emergent BioSolutions Inc.)
07.2024 - Current
Quality Assurance Specialist I
Bora Pharmaceutical Injectables Inc. (fka Emergent BioSolutions Inc.)
07.2023 - 07.2024
Master of Science - Biotechonology Management
University of Maryland Global Campus
09.2022 - Current
Quality Engineer, Analyst III
Bora Pharmaceutical Injectables Inc. (fka Emergent BioSolutions Inc.)
11.2021 - 07.2023
Lead Bioprocess Associate
Bora Pharmaceutical Injectables Inc. (fka Emergent BioSolutions Inc.)
09.2018 - 11.2021
Bachelor of Science - Biology
Howard University
09.2013 - 05.2017
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