Melissa Usher

WORK HISTORY

SKILLS

ABOUT MELISSA USHER

AS DIRECTOR OF QUALITY AND REGULATORY• Interface with customers during onboarding process and to support resolving of product/process issues• Perform role with a “no job too small” attitude, writing non-conformances and CAPAs, conducting training for Manufacturing staff, performing internal audits, etc.• Serve as Management Representative and host for all auditing body and customer audits• Member of the executive management team, responsible for developing and reporting out on Key Performance IndicatorsAS A QUALITY SYSTEMS MANAGER- Implemented a QMS and achieved ISO 13485 certification - Provided Quality oversight for bringing a new manufacturing facility online- Hosted all auditing body and customer audits- Conducted supplier qualification auditsAS A QUALITY ASSURANCE SUPERVISOR• Managed the Non-Conformance and CAPA systems• Designed a process for electronic documentation of NC reporting• Assisted in regulatory body audits• Compiled and present metrics to management• Coordinated the testing and performed the data analysis for the Stability Monitoring program• Determined disposition of finished goods through final review of release resultsAS A QUALITY CONTROL PROCESS ANALYST• Coordinated the testing and performed the data analysis for the Stability Monitoring program• Documented investigations, root cause analysis and corrective actions via NC and CAPA reports• Developed a new process for packaging finished goods• Managed the QC department training program• Facilitated/participated in Kaizen events to support Lean ManufacturingAS AN ANALYTICAL CHEMIST• Led the QC Stability Group that attained a 100% success rate of on-time sample testing and data release• Augmented the Analytical Development Department by performing qualification and validation experiments• Assisted in the preparation of the QC laboratory for a successful PAI inspection• Instituted a QC data trending program• Analyzed raw materials, in-process and final samples as required to support production and manufacturing• Excelled at document writing and reviewing to include SOPs, deviations, investigations, reports and protocolsAS A MEDICAL LABORATORY TECHNICIAN• Served as lead Chemistry Department analyst for 2 years• Conducted correlation studies to recapture in-house testing• Achieved 100% accuracy on all College of American Pathologist (CAP) surveys• Designated as the key operator of instruments, encompassing all training and preventative maintenance responsibilities