Maayan Daniel
Achuzat Baraq
Summary
Highly motivated, Hands-on on experienced, creative, and communicative researcher. A hardworking biologist with expertise in compounds and tie industry, microbiology, immunology and cytology. D Pursuing new professional challenges with the opportunity to make a positive impact on laboratory operations and research success. Skilled multitasker with excellent communication and problem-solving skills.
Overview
7
7
years of professional experience
1
1
Certification
Work History
QA and Regulatory Affairs Manager
TOSAF
02.2023 - Current
- Promoted a culture of continuous improvement by regularly reviewing and refining QA processes, tools, and methodologies.
- Conducted root cause analysis for defects, leading to targeted improvements in the production process.
- Enhanced employee awareness of compliance requirements by developing training programs focused on specific industry regulations or standards.
- Increased product reliability by performing thorough regression testing on each release cycle.
- Contributed to the continuous improvement of QA processes through regular reviews, evaluations, and updates as needed.
- Demonstrated new product features and functionality to project stakeholders.
- Participated in agile development practices such as sprint planning meetings and daily stand-ups, contributing valuable input from a QA perspective throughout the project life cycle.
- Assisted with regulatory product compliance initiatives.
- Consolidated global information relevant to the compony products and monitored global submissions and approvals status.
- Successfully navigated complex regulations for various types of medical devices or pharmaceutical products during their lifecycle stages.
- Prepared and maintained document inventory for core dossier preparation.
Research Lab Manager
Nutaria
03.2022 - 12.2022
- Handled new study start-up for research trials, scheduling and follow-up activities.
- Designed processes to increase efficiency by minimizing error and reducing repetitive tasks.
- Knowledge of ISO standards, especially experienced with ISO 9000, ISO 45000
- Planned and coordinated new development programs to meet deadlines within $300K budget.
- Managed operational documents and produced weekly reports detailing activities.
- Developed and tested formulas for SLN products to find high quality, low cost options.
- Bench work
- Completed workplace safety and hazard inspections.
- Kept main work areas free of debris and obstacles that could cause falls and mishaps.
Cytotechnologist
Ha-Emek hospital
11.2019 - 02.2022
- Examined cell samples to detect abnormalities in color, shape or size of cellular components and patterns
- Analyzed cell component color, size and shape to detect patterns and abnormal occurrences
- Observed all defined lab protocols in regard to specimen processing and collection, maintaining standards to promote accuracy and precision in results
- Evaluated abnormal cell structures and consulted with pathologists to gain further data about identified features
- Assisting physicians at fine needle aspirations procedure with on-site collections
- Preparing cytology specimens of gynecologic and non-gynecologic samples, body fluids and fine needle aspirations procedures (FNA)
- Developing and updating technical policy and procedure manuals
- Created plans and communicated deadlines to ensure projects were completed on time.
- Knowledge of ISO standards, especially experienced with ISO 9000, 9001, ISO 45000 and ISO 14001
- Established and tracked quality department goals and objectives.
- Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk and improving throughput.
- Recorded, analyzed and distributed statistical information.
AGRICULTURAL RESEARCHER ASSISTANT
Ministry Of Agriculture
04.2017 - 04.2019
- Used critical thinking to break down problems, evaluate solutions and make decisions
- Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity
- Developed and maintained courteous and effective working relationships
- Bench work including molecular and cell biology assays
- Created spreadsheets using Microsoft Excel for daily, weekly and monthly reporting
- Documented experiment progress and observations, compiled data and organized findings for analysis
- Boosted team efficiency by organizing, restocking and maintaining laboratory environments and equipment
- Maintained energy and enthusiasm in fast-paced environment
- Collaborated with leadership team to identify relevant questions and determine best methods of collection.
Education
M.Med.Sc - Microbiology And Immunology
Ben Gurion University
Beer Sheva2016
Bachelor of Science - Biology
Ben Gurion University
Beer Sheva2013
Skills
- DNA, RNA and protein extraction
- Western blot
- QPCR
- Cell culture
- Plasmid cloning
- Restriction enzyme digestion
- Flow cytometry
- Particle size analysis
- Drug development
- Corrective Actions
- Automotive Industry
- Hands-on experience in in-vivo and in-vitro experiments
- Cytology screening
- Bioinformatics Multiple sequence alignments
- Multitasking abilities
- Organization and Time management
- Regulatory Submissions
- Global Regulatory Compliance
- ISO and IATF1649 Standards
- FDA Interactions
- Internal Auditing
- Root Cause Analysis
Languages
Hebrew
Native language
English
Proficient
C2
Certification
- Internal and 2nd party Quality Auditor IATF 16949:2016- [2023]
- Dangerous Goods Training - [2024]
Timeline
QA and Regulatory Affairs Manager
TOSAF
02.2023 - Current
Research Lab Manager
Nutaria
03.2022 - 12.2022
Cytotechnologist
Ha-Emek hospital
11.2019 - 02.2022
AGRICULTURAL RESEARCHER ASSISTANT
Ministry Of Agriculture
04.2017 - 04.2019
M.Med.Sc - Microbiology And Immunology
Ben Gurion University
Bachelor of Science - Biology
Ben Gurion University
Similar Profiles
Yuval StarostaYuval Starosta
Chief Technology Officer at TosafChief Technology Officer at Tosaf
David FrameDavid Frame
QA & Regulatory Affairs Manager at Babylon Health (Software as a Medical Device)QA & Regulatory Affairs Manager at Babylon Health (Software as a Medical Device)
AKHILA KUMMARIAKHILA KUMMARI
Sr. Manager - Project Mgmt. & Regulatory Affairs at GeneSys Biologics Private LimitedSr. Manager - Project Mgmt. & Regulatory Affairs at GeneSys Biologics Private Limited
Khushal GiteKhushal Gite
Deputy Manager - Global Regulatory Affairs, at Apotex Research Pvt LtdDeputy Manager - Global Regulatory Affairs, at Apotex Research Pvt Ltd
Khadija Al ShehhiKhadija Al Shehhi
Medical Laboratory Technician Intern at Abdullah Bin Omran Hospital for Obstetric and GynecologyMedical Laboratory Technician Intern at Abdullah Bin Omran Hospital for Obstetric and Gynecology