Senay Berhe
Minaris
Baltimore,USA
1
Certification
7
years of professional experience
Results-driven scientist with demonstrated ability to enhance laboratory operations through precise and reliable work. Skilled in developing and optimizing protocols that improve efficiency and accuracy. Known for strong collaborative skills and adaptability in dynamic environments, ensuring team success and consistent results.
Work History
QC Lab Specialist
2 Months- Managed equipment calibration processes, ensuring compliance with regulatory standards and enhancing operational efficiency.
- Developed and implemented standard operating procedures for laboratory protocols, improving consistency and accuracy of results.
- Led cross-functional teams in troubleshooting technical issues, driving timely resolutions to maintain project timelines.
- Established partnerships with external laboratories to expand available resources and capabilities for specialized testing needs.
- Provided expert guidance during complex investigations, ensuring accurate interpretation of findings and conclusions.
- Collaborated with cross-functional teams to implement IT solutions that enhanced operational efficiency.
- Optimized system performance, conducting routine checks and addressing potential issues before escalation.
Quality Lab Engineer (Contract)
1 Year 6 Months- Developed and maintained document control systems for efficient retrieval and storage of critical information.
- Ensured timely completion of all scheduled calibration activities, maintaining high standards of quality withing QC, QA, AD, & Manufacturing.
- Maintained comprehensive records of calibration activities, repairs, and equipment status to ensure compliance and traceability.
- Troubleshot mechanical and procedural issues to support calibration activities, ensuring minimal downtime.
- Point of Contact for instruments with vendors, saved 20% on instrument budget through negotiation.
- Coordinated preventive maintenance schedules for critical equipment pieces to ensure uninterrupted operations within the laboratory setting.
- Provided expert guidance on troubleshooting methods used in resolving technical issues faced by fellow researchers thereby enhancing their productivity levels.
- Collaborated with Validation and created new Periodic Review system.
- Monitored compliance with regulatory requirements, maintaining up-to-date knowledge of industry standards and best practices.
- Documented and developed engineering procedures and processes.
- Trained junior staff members on proper laboratory techniques, fostering a collaborative work environment.
- Troubleshot issues related to instrumentation setup or calibration providing timely resolution of discrepancies impacting daily tasks.
- Led engineering teams to successfully complete projects on time and within budget.
- Provided technical support for hardware and software issues, ensuring minimal downtime for end-users.
Senior Quality Control Analyst
1 Year 11 Months- Facilitate meetings between departments, to isolate and identify areas of underperformance, create solutions, and increase efficiency.
- Developed and implemented environmental monitoring protocols for EMPQ compliance.
- Laboratory investigations, OOS/OOT, CAPA, Change Control, Quality Incidents (Deviations), Electronic Document Management, Risk Assessment.
- Data trending for assay controls and critical reagents.
- Contribute to CAPA teams and initiate investigations for deviations.
- Data Revision, correction, and verification.
- Provided quality system guidance and support for QC laboratories, including data review processes to ensure the health of quality systems.
- Developed comprehensive training materials, contributing to the professional development of junior analysts and improving overall team performance.
- Provided active support for QC site operations, including facilities, lab operations, and IT operations.
- Evaluated current document processes, suggested methods for change and implemented successful improvements.
- Supervised team in maintaining up-to-date records, ensuring compliance with industry standards and regulations.
Lead Quality Control Analyst
1 Year 6 Months- 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.
- Conducted EMPQ studies to qualify new cleanrooms.
- Data Revision, correction, and verification.
- Mastered various laboratory techniques such as protein purification, chromatography, electrophoresis, spectroscopy, among others throughout the internship duration.
- Developed monthly and end-of-quarter statistical reports for quality improvement programs.
- Performed cell-based potency and impurity assays for in-process, release, and stability samples.
- Created and maintained several databases to track statistical data.
- Streamlined document management processes to enhance retrieval efficiency and accuracy.
- Developed and maintained comprehensive filing systems for regulatory compliance and accessibility.
Document Control Specialist
1 Year 2 Months- 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.
- Prepared production documents such as standard operating procedures, manufacturing batch records and productivity reports.
- Inspected finished products for quality and adherence to customer specifications.
- 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.
- Managed document lifecycle processes to ensure compliance with industry standards and regulations.
- Collaborated with cross-functional teams to streamline documentation workflows and improve accuracy.
Education
B.S. - Biochemistry
Skills
Mastercontrol
QMS
Calibration
Troubleshooting
Investigation
CAPA Management
Change Control
Corrective Action Implementation
Trackwise
Empower
Periodic Review
Aseptic Technique
Python programming basics
Risk Assessment
Vendor Liaison
Artificial intelligence implementation/development
Certification
Certified Pharmacy Technician (PTCB),
Microsoft Word and Excel Certified,
NVIDIA Certification
Timeline
QC Lab Specialist
Minaris
07.2026 - CurrentRead More
Quality Lab Engineer (Contract)
FUJIFILM Diosynth Biotechnologies
01.2025 - 07.2026Read More
Senior Quality Control Analyst
Takeda
11.2022 - 10.2024Read More
Lead Quality Control Analyst
Catalent
04.2021 - 10.2022Read More
Document Control Specialist
Meso Scale Discovery
02.2020 - 04.2021Read More
University of Maryland, Eastern Shore
B.S. from Biochemistry
Read More