Experience

Chembio Diagnostics, Inc.

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Sr. Manager QA/QC/QMS

  • Jul 2021 - Present



Unilever

• United Kingdom
• Manufacturing
• 700 & Above Employee

• QA/QC Manager

  • Aug 2017 - Jul 2021



PharmaForce, Inc.

• United States
• 1 - 100 Employee

• Sr. Supervisor QA Operations

  • Mar 2016 - Aug 2017

  Lead on-site QA activities in investigating deviations, CAPAs, or other compliance issues, resulting in the resolution of one year of backlog in CAPAs and deviation closures. Identify and facilitate with senior management, process improvements resulting in the revision of existing SOPs and other cGMP documentation. Provide leadership to more than eight technicians to assure quality oversight of daily production activities. Offer support to my team by ascertaining and enabling individual performance goals, administering training plans and productivity metrics, and providing feedback to ensure a collaborative work environment for maximum efficiency and output.



Fougera Pharmaceuticals Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Operations Group

  • Nov 2011 - Nov 2015

  Responsible for ensuring full manufacturing operations compliance is met per Quality guidelines for FDA, ICH, cGMP, and OSHA. Managed the preparation and closure of all CAPA within the corporation resulting in reduced critical defects for future manufacturing lines. Entrusted with the audits of manufacturing operations resulting in the closure of an average 90% investigation reports for deviations per month. Pioneered the first safety team to conduct monthly OSHA audits for Melville location, reducing safety incidents by 33% in its first year.



Aurolife Pharmaceuticals

• QA Operations

  • Jan 2010 - Nov 2011

  QA Team lead providing leadership to four QA’s to achieve operational excellence through process of inspection and testing of raw materials, analysis of data, and corrective action. Assisted executive management with FDA/OSHA inspections, establishing systems and procedures to ensure cGMP compliance, and establish regulatory guidelines and client specific requirements. QA Team lead providing leadership to four QA’s to achieve operational excellence through process of inspection and testing of raw materials, analysis of data, and corrective action. Assisted executive management with FDA/OSHA inspections, establishing systems and procedures to ensure cGMP compliance, and establish regulatory guidelines and client specific requirements.



Forest Laboratories (now Allergan)

• Pharmaceutical Manufacturing
• 500 - 600 Employee

• QA Associate

  • Oct 2007 - Sep 2009

  Collaborated with cross-functional teams of multiple products to ensure compliance of clinical trials to FDA regulations. Accountable for various quality tasks (inspection, testing, analysis) on production lines to ensure timely release, for smooth and accurate manufacturing of company products. Collaborated with cross-functional teams of multiple products to ensure compliance of clinical trials to FDA regulations. Accountable for various quality tasks (inspection, testing, analysis) on production lines to ensure timely release, for smooth and accurate manufacturing of company products.