EMIRE DEMIRAYAK
Fremont,CA
Summary
Chemist with an MS in Inorganic Chemistry and 9 years of experience in pharmaceutical and testing companies. Skilled in Quality Metrics, Clinical Change Management, Supply Chain Tables, Trial Master File, supporting clinical QP lot release activities, Commercial Batch Record Review, and Lean Yellow Six Sigma certified. Proficient in quality assurance processes and methodologies to ensure products meet high standards. Utilizes keen attention to detail and analytical skills to efficiently identify and resolve issues. Demonstrated track record of maintaining quality through effective execution, fostering excellent collaboration with cross-functional teams, and adapting to shifting project needs.
Overview
13
13
years of professional experience
1
1
Certification
Work History
QA Specialist II
Gilead Sciences
04.2020 - Current
- Quality Management Review (QMR)
- Support collection of data and information from various functional areas quarterly
- Support to maintain schedules and milestones (including notifying the stakeholders, coordinating with them, and addressing questions as necessary)
- Support other QMR logistics activities
- Support the new QMR Model process improvement
- Generation and analyzing of deviations, CAPA, and change control metrics
- Award(s): Applause Award by Marissa Kane and Michael Inzitari (Dec2024)
- Values at Work Award by FC QMR Logistics Team for contributions (Nov2023)
- External Quality Operations (EQO) Monthly Core Metrics
- Coordinate data collection and the presentations from stakeholders
- Coordinate the generation of core metrics data, analyze the data, and provide key messages and insights to the EQO leadership
- Work with cross-functional teams and stakeholders to ensure data completeness and accuracy
- Facilitate monthly meetings with the EQO leadership and address questions
- Award(s): Values at Work Award by EQO Leadership for leading EQO Monthly Core Metrics (Jun2023)
- Clinical Change Management (CCM)
- Support and coordinate generating data and metrics and presentation monthly
- Support and coordinate activities related to clinical change management as requested by management and support the team with inquiries
- Support in resolving clinical supply chain table (SCT) issues found by Qualified Person
- Trialog Israel Batch Release
- Trial Master File (TMF) Management
- TMF SME, to prepare and participate in all GCP, GMP, and FDA inspections
- Award(s): GThanks; by product team for the PMDA inspection readiness support (Apr2024)
- Quality Assurance Development Operations Support
- Clinical Drug Product Expiration Date Extensions
- Award(s): GThanks; by product team for supporting an urgent request gating multiple lots release (Apr2024)
- Support and coordinate Lot Number assignments and revise IQS LN records to support Batch Disposition and assign the 2-letter code for new Clinical Drug Products
- Award(s): GThanks; by product teams for support urgent the DP manufacturing process (Nov2023)
- Assist the department in issuing Memos, governance procedures, and route for approval in Veeva Vault QDMS to support business needs
- Support the process of Shipping and Site Excursion Investigation completion and product disposition
- Improvement Projects/Accomplishments:
- Created a new platform for Trialog Israel Batch Release Support Requests in JIRA(on-going)
- Provided SCT Refresher Trainings to the clinical supply chain teams (Sep2023 and Jan2024)
- Created SCT Refresher training curricula to maintain 100% clinical SCT accuracy (Jan2024)
- Converted MTR (Material Transfer Request) Manual Logbook to electronic Logbook (Aug2023)
- Converted the GPLM QA Approver Training into web-based training in Veeva Vault (Apr2023)
- Converted physical QMR Archival form to electronic form in Veeva Vault (Apr2023)
- Supported the inspection readiness procedural revisions and created an inspection questionnaire (previously asked questions) to help QA colleagues with inspection readiness (Nov2023)
Assistant Scientist I
Eurofins Scientific
08.2018 - 04.2020
- Work on 20+ projects, including carrying out from the beginning to end of the study analysis of soil photolysis and aerobic/anaerobic metabolism of 14C-related projects as a leading analyst without any QA audit findings
- Used 5+ diverse range of analytical methods for investigation of test substance in a test system
- Documentation, definition, and confirmation materials using ChemStation, Laura, ImageQuant, and Radiochromatogram Program
- Documentation and interpretation of data for analysis result report and further analysis
- Created end-of-study draft reports, including study details and wet and instrumental analysis results, once in 8 months
- Perform technical reviews of analytical data and prevented having major findings for over 10 studies
- Perform a diverse range of analytical methods for investigation of a test substance in a test system
- Excel at Solid Phase Extraction (SPE), Thin Layer Chromatography (TLC), and High-performance Liquid Chromatography (HPLC)
- Data entry and interpretation
- Documentation of work performed in laboratory notebooks, worksheets, instrument logbooks, or other printed documents as per applicable SOP and GLP guidelines
- Assist with the organization and maintenance of raw data binders
- Helping maintain assigned laboratory instruments and equipment
- Contribute to preparation of data summaries, draft reports, and response to QA audits
- Troubleshoot and resolve problems encountered with tasks listed above
Technical Specialist
SGS Turkey
04.2015 - 10.2017
- Company Overview: An international inspection, verification, certification, and testing company with 10,000+ employees in 50+ countries
- Reduced non-GLP environment and built GLP culture in the chemical laboratory in first 8 months, created all validation and certainty documents from scratch for all tests in a year, created 50+ SOP, and updated existing SOPs according to QA requirements in a 1-year period
- Provided trainings to 100+ chemical lab staff and technicians to create GLP perception in the first 6 months
- Led over 30 internal audits; improved compliance and accomplished a complete GLP environment in the lab
- Achieved 90% no-findings external audits by performing internal audits, creating and following up CAPAs
- Preparing quality documents, validation, and uncertainty reports of tests
- Quality support in writing, reviewing, revising, and maintaining standard operating procedures (SOPs), test methods, worksheets, and other business documents
- Assure documents capture the current process, provide sufficient detail to perform the process and comply with internal procedures for generating documents
- Cooperate in the preparation of study files prior to and during all client audits and regulatory inspections
- Follow up on calibration periods of all the devices in the laboratory and ensuring that all devices' calibrations are up-to-date
- Assist with internal audits to ensure compliance is maintained within the organization
- May provide audit reports to the applicable audited function/area management according to GLP and ISO 17025 quality systems
- Perform document control activities
- Support the training program by creating training files and ensuring that they are updated and current as appropriate
- Attending meetings and participating on multi-disciplinary teams, as required, to provide routine status updates related to their functional area and/or to provide quality guidance
- An international inspection, verification, certification, and testing company with 10,000+ employees in 50+ countries
Quality Control Analyst
Recordati Pharmaceuticals
04.2012 - 08.2014
- Company Overview: An international pharmaceutical group serves the therapeutic areas worldwide
- Carrying out raw materials instrumental (HPLC, GC, and FTIR) and wet chemistry analysis, and water/moisture content analysis
- Ensure draft reports and analytical data prepared in a timely manner and accomplished with minor errors in a short period before starting production of the drugs
- Support creating the methods of analysis, completed over 20 methods in a short period
- Row materials instrumental (HPLC and GC) and wet chemistry analysis
- Carrying out analytical activities within the Row Materials
- Ensuring draft reports and analytical data preparation in a timely manner and the meanwhile, preparing the methods of analysis
- Main competencies developed: Analyzing, reporting, teamwork, time management, crisis management
- An international pharmaceutical group serves the therapeutic areas worldwide
Education
Master of Science (MS) - Anorganic Chemistry
Istanbul University
IstanbulBachelor’s Degree - Chemistry
Istanbul University
IstanbulSkills
- GLP and GMP environment work culture
- Problem solving
- Process improvement
- Experience with QA principles, industry practices and standards
- Capability to work effectively with cross-functional teams
- Data collection, interpretation, reporting
- QA auditing and documentation
- Knowledge of risk management principles
- Staff training and development
- Microsoft Office (Word, Excel, PowerPoint, Teams)
Accomplishments
- Received Key Contributor Award in August 2024
- Achieved 100% quality records closure and turnaround time through effectively helping Biologics QA Teams
- Improved Management of Trialog-Israel Batch Release process by creating a new request platform
- Achieved 100% Clinical Supply Chain Table accuracy by providing trainings to clinical supply chain teams
- Achieved to save 20+ hours per month by converting GPLM Training for QA from Instructor Led Training to a Web Based Training
Professional Development
- Principles of Biomanufacturing Course (online), MIT, 2024
- Oral Solid Dose Batch Record Reviews Qualification, 2024
- Agile Process, Project and Program Controls Course (edX), University of Maryland, 2023
- Gilead Alberta API Manufacturing Training, 2023
- Lean Yellow Belt Six Sigma Certificate, Gilead Sciences, 2022
- ISO 17025 Internal Auditor Certificate, SGS Supervise Turkey, 2016
Certification
- Lean Six Sigma Yellow Belt -Gilead Siences
- Agile Process, Project, and Program Controls - Maryland University
Languages
English
Full Professional
Turkish
Native or Bilingual
Timeline
QA Specialist II
Gilead Sciences
04.2020 - Current
Assistant Scientist I
Eurofins Scientific
08.2018 - 04.2020
Technical Specialist
SGS Turkey
04.2015 - 10.2017
Quality Control Analyst
Recordati Pharmaceuticals
04.2012 - 08.2014
Master of Science (MS) - Anorganic Chemistry
Istanbul University
Bachelor’s Degree - Chemistry
Istanbul University
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