Keenan Mert
Auburn,WA
Overview
4
4
years of professional experience
Work History
QC Associate: Microbiology
Bristol Myers Squibb
09.2022 - Current
- Applied the principles of cGMPs daily in conducting Environmental Monitoring in ISO classified rooms, ensuring compliance with regulatory standards and maintaining the integrity of the cleanroom environments.
- Experienced in analyzing and compiling data for BacT and Endotoxin assays, and proficient in the preparation of detailed reports and presentations to support laboratory findings and quality control measures.
- Served as a Subject Matter Expert (SME) for Environmental Monitoring and assay testing methods, providing critical knowledge and guidance in laboratory procedures and system operations.
- Demonstrated strong troubleshooting skills in identifying and resolving laboratory or system anomalies, particularly in the use of LIMS and conducting various microbiological assays.
- Led laboratory investigations to address quality events, deviations, and anomalies, employing systematic approaches to identify root causes and implement corrective actions.
- Acted as a Quality Control representative on cross-functional project teams, collaborating with other departments to ensure quality standards are met across all stages of product development and manufacturing.
- Contributed to the optimization of Quality Processes through continuous improvement initiatives and effective troubleshooting of microbiological methods.
- Demonstrated proficiency in computerized systems, particularly in the use of Laboratory Information Management Systems (LIMS), enhancing data management and operational efficiency in the laboratory.
QC Associate
AGC Biologics
11.2019 - 09.2022
- Evaluating samples against standards by completing measurements, visual inspections, and other established tests
- Tracking collected specimens by initialing, dating, and noting times of collection according to company standards
- Performing real-time assays to support QC Chemistry and protein concentration by UV spectrophotometry
- Executing cross-site validation protocols, supporting assay transfers, and providing data to support final reports
- Reviewing batch records, entering specimen data, and revising documents in the Lab Information Management System
- Supporting LIMS consultants in improving the user interface and expanding LIMS to accommodate more products
- Maintaining instrumentation and equipment, overseeing preventive maintenance, and calibrating laboratory equipment
- Supporting FDA audits, revising documents including SOPs, and logging laboratory data for a variety of processes
- Performing ELISA tests along with pH, Osmolality, and Conductivity assays and training staff in assay procedures.
Education
MBA -
Washington State University Carson College of Business
Global Campus06.2025
Bachelor of Science in Biology with a Minor in Psychology -
Washington State University
Pullman, WA06.2017
Skills
- Aseptic techniques
- Assay Transfers & Batch Records
- Audit Assistance
- cGMP & Laboratory Standards
- Deviations, CAPAs & Investigations
- Endotoxin
- Environmental monitoring
- Equipment Calibration & Controls
- FDA & OSHA Regulatory Compliance
- JMP-Pro 12
- Java/Java Script
- Lean Six Sigma (White Belt)
- LIMS (LabWare 7/8)
- Laboratory Assistance & Testing Procedures
- MYLA
- Microbiological testing
- Microsoft Office Suite: Word, Excel, Outlook, PowerPoint
- Quality SOPs Development
- SQL Server
- Stability sampling
- Staff Training
- UV Spectrophotometry
Languages
Turkish
Native or Bilingual
Russian
Native or Bilingual
Certification
Lean Six Sigma White Belt
Timeline
QC Associate: Microbiology
Bristol Myers Squibb
09.2022 - Current
QC Associate
AGC Biologics
11.2019 - 09.2022
MBA -
Washington State University Carson College of Business
Bachelor of Science in Biology with a Minor in Psychology -
Washington State University
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