Meltem Colak

• • Improved and streamlined Environmental Monitoring (EM) data entry
• • Revised microbial contamination/cross-contamination risk assessment reports.
• • Performed trending and analysis for environmental monitoring and utility data to maintain regulatory standards.
• • Supported continuous improvement efforts within the organization by regularly reviewing existing processes and suggesting enhancements when necessary.
• • Authored quarterly EM trend reports, ensuring comprehensive data analysis and compliance.
• • Supported FDA ANNEX 1 gap assessments to identify and address regulatory discrepancies.
• • Organized and improved trending data systems, enhancing accuracy and usability for regulatory and operational purposes.
• • Supported senior leadership by preparing and delivering presentations on EM data and trends.
• • Maintained daily trending activities to ensure continuous monitoring and prompt identification of deviations or concerns.

• Fostered a culture of quality within the department, ensuring compliance with regulatory agency requirements and cGMP standards.

• Coordinated and monitored daily departmental operations based on projected client demands, optimizing resource allocation and task completion.

• Reduced scheduling inefficiencies by streamlining departmental scheduling processes and independently managing meeting coordination. Implemented new schedule process.

• Managed department CAPA and change control processes, driving continuous improvement in operational efficiency.

• Collaborated in cross-functional and departmental meetings to align objectives and enhance communication across teams.

• Maintained audit readiness by ensuring staff training, comprehensive documentation review, and laboratory cleanliness.

• Interfaced clients to address sampling, reporting, and issue resolution effectively.

• Supervised direct and indirect reports, assigned tasks, and conducted performance appraisals.

• Supported leadership by overseeing timely completion of daily activities across both first and second shifts during change of leadership.

• Improved lot release by ensuring the accuracy and integrity of environmental monitoring (EM) data.

• Conducted internal audits to identify gaps, ensure compliance, and drive process improvements.

• Authored and implemented procedural updates to maintain compliance with evolving regulatory requirements.

• Assisted in interviewing, onboarding, and cross-training employees across all departmental functions, enhancing team versatility and performance.

• Facilitated the coordination and planning of company-wide events and team bonding activities, enhancing internal collaboration and morale.

• Lead quality assurance program for entire lab by performing a broad-spectrum of tasks
• Managed laboratory Move to a new location
• Monitored staff organization and suggested improvements to daily functionality
• Managed Equipment Validation
• Play an integral role in investigating complaints and non-conformance reports
• Devise and execute corrective actions, while reviewing data for optimum accuracy
• Oversee the documents database and issue controlled copies, ensuring full data integrity
• Manage the QC sample program as well as analyze qc data and prepare charts
• Distinguished in efficiently administering the ISO17025 quality management system
• Ensured completion of routine work by adding/changing corporate documents
• Managed and completed the ISO Audit with zero nonconformities
• Delivered comprehensive training to the cross-functional professionals on the quality system and technical SOPs
• Streamlined a new training program
• Supported audits and led teams to fully investigate quality control processes and root out deficiencies.