SENAY BERHE
BALTIMORE,MD
Summary
Biochemical professional with expertise in general chemistry and biology principles, lab practices, and systems. Performs with elevated levels of productivity in fast-paced environments, while consistently meeting and exceeding all deadlines. Recognized for leadership and problem-solving skills, as well as thoroughness and accuracy. Experienced in developing and executing manual and automated test cases. Highly proficient in testing tools, systems and software.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Senior Quality Control Analyst
Takeda
11.2021 - Current
- Facilitate meetings between departments, to isolate and identify areas of underperformance, create solutions, and increase efficiency
- Laboratory investigations, OOS/OOT, CAPA, Change Control, Quality Incidents (Deviations), Electronic Document Management, Risk Assessment
- Utilized advanced analytical techniques such as HPLC and spectrophotometry to accurately assess contaminant levels in water samples.
- SDS-Page, Capillary Electrophoresis, Processes implementation, Material handling expert, Assembly line production, In-depth OSHA, FDA, and ISO knowledge
- Data trending for assay controls and critical reagents
- Performed trend analysis for stability and method performance
- Contribute to CAPA teams and initiate investigations for deviations
- Data Revision, correction, and verification
- Coordinated with cross-functional teams for project management
- Organized timelines for project management properties
- Chemical processing, Safety Operation Procedures, CAPA/Predictive and Preventative Maintenance, Data Analysis, Root Cause Analysis, Calibration, Troubleshooting Technical Issues, Image Analysis.
- Developed comprehensive training materials, contributing to the professional development of junior analysts and improving overall team performance.
Lead Quality Control Analyst
Catalent
04.2021 - 10.2021
- Performs routine and non-routine testing for chromatographic and spectrophotometric methods of analysis in support of Pharmaceutical API and product development.
- Mastercontrol and Trackwise proficiency, initiating deviations and investigations, conduct root cause analysis and implement solutions
- Utilized microscopy, spectrophotometry and chromatography following procedures for accurate results.
- Developed proficiency in various laboratory techniques such as PCR, chromatography, microscopy, and cell culture maintenance, leading to high-quality outcomes.
- Data Revision, correction, and verification
- Mastered various laboratory techniques such as protein purification, chromatography, electrophoresis, spectroscopy, among others throughout the internship duration.
- Knowledge of global regulatory expectations (FDA and EMA included)
- Prepare and update files per SOP
- Manage multiple projects effectively, efficiently, and contemporaneously
- Developed monthly, end-of-quarter, and other statistical reports for quality improvement programs
- HPLC based methods commonly employed along with Titrations, UV, and IR
- Performed cell-based potency and impurity assays for in-process, release, and stability samples
- Created and maintained several databases to track statistical data.
Quality Control Analyst
Meso Scale Discovery
02.2020 - 04.2021
- Completes/reviews validation protocols, deviation reports, change controls in accordance with cGMP's
- Author/review/improve SOP's, batch records, protocols, and technical reports
- Handling/completion of batch documentation
- Mix/Make/Handle reagents and solutions such as Triton, NaOH, HCl, Kathon Water, Phosphorus Reagent etc
- Calibrated machines to maintain required productivity levels and adherence to quality standards
- Prepared production documents such as standard operating procedures, manufacturing batch records and productivity reports
- Inspected finished products for quality and adherence to customer specifications
- Achieved aggressive production and quality requirements
- Facilitated and fixed production problems to reduce overall defect rates
- Performed routine maintenance and calibration on testing equipment
- Performed visual assessment of products to evaluate conformance with quality standards.
- Conducted root cause analysis for recurring issues, developing long-term solutions to prevent recurrence.
Education
B.S.-Biochemistry -
University of Maryland, Eastern Shore
Princess Anne, MD12.2018
Skills
- Mastercontrol
- Trackwise
- QMS
- Strong Proficiency in Computer Applications
- TOC
- Empower
- HPLC
- Bioburden Testing
- Endotoxin Testing
- FMEA
- CAPA Management
- Root Cause Analysis
- Change Control
- Risk Assessment
- Corrective Action Implementation
- Gas chromatography
Certification
- Certified Pharmacy Technician (PTCB)
- Microsoft Word and Excel Certified
Timeline
Senior Quality Control Analyst
Takeda
11.2021 - Current
Lead Quality Control Analyst
Catalent
04.2021 - 10.2021
Quality Control Analyst
Meso Scale Discovery
02.2020 - 04.2021
B.S.-Biochemistry -
University of Maryland, Eastern Shore
- Certified Pharmacy Technician (PTCB)
- Microsoft Word and Excel Certified
Similar Profiles
Samuel Anselmo SimõesSamuel Anselmo Simões
Senior Treasury Analyst at TakedaSenior Treasury Analyst at Takeda
Aidan AtwalAidan Atwal
Pharmaceutical Sales Representative at TakedaPharmaceutical Sales Representative at Takeda
Anthony MundayAnthony Munday
Senior Research Associate II at TakedaSenior Research Associate II at Takeda