Commissioning Qualification Manager

• Nov 2021 - Present

Manage team responsible for performing commissioning and qualification activities for bio containment and GMP pharmaceutical laboratories. Manage team responsible for performing commissioning and qualification activities for bio containment and GMP pharmaceutical laboratories.

Validation Manager

• May 2019 - Oct 2021

QA Validation Specialist III

• Apr 2018 - Apr 2019

Staff Quality Engineer

• May 2017 - Jan 2018

Responsible for supplier quality, contract manufacturing quality management, management of internal plant validation department and supervising quality engineering staff.

Senior Quality Engineer

• Jul 2015 - May 2017

Senior Quality Engineer

• Mar 2014 - Jul 2015

Quality Engineer

• Mar 2012 - Mar 2014

CORE RESPONSIBILITIES: SUPPLIER QUALITY ENGINEERING •Continually work with chemical suppliers to improve performance, implement process control and quality plans. •Interact routinely with purchasing, engineering and suppliers to pro-actively improve quality of raw materials. •Analyze supplier capabilities. Develop and maintain supplier quality metrics and trending analysis. •Perform on-site and desktop quality systems audits and provide support for supplier systems… Show more CORE RESPONSIBILITIES: SUPPLIER QUALITY ENGINEERING •Continually work with chemical suppliers to improve performance, implement process control and quality plans. •Interact routinely with purchasing, engineering and suppliers to pro-actively improve quality of raw materials. •Analyze supplier capabilities. Develop and maintain supplier quality metrics and trending analysis. •Perform on-site and desktop quality systems audits and provide support for supplier systems improvements. •Drive improvement through lean six sigma initiatives and DMAIC principles. PROCESS VALIDATION ENGINEERING •Perform process validation for new OTC drug products and process improvements. •Interact routinely with R&D, Engineering and Operations for validation requirements, planning and execution . •Write protocols, summary reports and analyze validation data. •Update and maintain validation matrix, validation logs and validation metric trending analysis reports. CONTRACT MANUFACTURING QUALITY ENGINEERING •Perform on-site quality systems audits for new and existing contract manufacturers. •Interact routinely with contract manufacturer’s quality and operation departments. •Perform trending analysis of quality metrics and work to drive continuous improvements. •Oversee all customer approvals, notifications and support requirements.

Quality Assurance Supervisor

• Jul 2010 - Mar 2012

•Oversee workers including leads, inspectors, or laboratory workers engaged in testing activities. •Identify deviations from established product or process standards and provide recommendations for resolving deviations. •Identify, create and implement inspection and testing criteria or procedures for critical to quality parameters. •Communicate quality control information to all relevant organizational departments, outside vendors, or contractors. •Discuss inspection results with… Show more •Oversee workers including leads, inspectors, or laboratory workers engaged in testing activities. •Identify deviations from established product or process standards and provide recommendations for resolving deviations. •Identify, create and implement inspection and testing criteria or procedures for critical to quality parameters. •Communicate quality control information to all relevant organizational departments, outside vendors, or contractors. •Discuss inspection results with those responsible for products, and recommend necessary corrective actions.

Process Engineer

• Aug 2007 - Jul 2010

•Technical leader on the Process Development Team, working with both internal and external manufacturers. •Procurement and IQ/OQ of new processing equipment and the process qualification/validation of new formulations. •Utilize creative drive to take new process concepts from inception to final commercialization. •Identify opportunities or implement changes to improve products or reduce costs utilizing knowledge of chemical processes, statistical process control, design of… Show more •Technical leader on the Process Development Team, working with both internal and external manufacturers. •Procurement and IQ/OQ of new processing equipment and the process qualification/validation of new formulations. •Utilize creative drive to take new process concepts from inception to final commercialization. •Identify opportunities or implement changes to improve products or reduce costs utilizing knowledge of chemical processes, statistical process control, design of experiments, establishing quality control standards, and product design. •Determine root causes of failures using statistical methods and recommend changes in designs, tolerances, or processing methods. •Troubleshoot new or existing product problems involving designs, materials, and processes

R&D Process Technician

• Jun 2003 - Aug 2007

•Pilot and scale up new processes and formulations, perform batch adjustments, process changes and improvements. •Create, review and manage batch cards from small scale to full scale commercialization. •Train manufacturing employees on new or existing processes, safety practices and improvement plans. •Perform tests and monitor performance of processes throughout stages of development to determine degree of control over variables such as temperature, time, specific gravity, and… Show more •Pilot and scale up new processes and formulations, perform batch adjustments, process changes and improvements. •Create, review and manage batch cards from small scale to full scale commercialization. •Train manufacturing employees on new or existing processes, safety practices and improvement plans. •Perform tests and monitor performance of processes throughout stages of development to determine degree of control over variables such as temperature, time, specific gravity, and pressure.

R&D Lab Technician

• Jan 2003 - Jun 2003

Microbiologist

• Jun 2000 - Jan 2003

•Oversee microbiology lab; perform daily testing and evaluations of raw materials, bulk and finished goods. •Perform root cause analysis investigations; perform organism identification, environmental monitoring and cleaning validation studies. •Design, and execute preservative effectiveness testing for new and existing product formulations.

Quality Control Lab Technician

• Sep 1999 - Jun 2000

•Monitor product quality to ensure compliance with standards and specifications. •Set up and conduct chemical experiments, tests, and analyses, using techniques such as chromatography, spectroscopy, physical or chemical separation techniques, or microscopy.