Experience

Nostrum Laboratories, Inc.

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Technical Operations Supervisor

  • Mar 2020 - Present

  Ensures that manufacturing is going smoothly, operators are properly trained and deadlines are met in a way that coincides with cGMP. Conducts investigations in a timely fashion and works with QA to come to a resolution, also reviews investigations as department management. Coordinates with QA and QC on the release or conditional release of raw materials needed. Works with several departments when changes are needed to SOPs or production records to ensure they align with current practices, company policy and FDA/DEA compliance. Reviews document change notices, reports, protocols and batch records with extreme attention to detail. Ensures that preventative work orders are completed and that any needed equipment changes are documented properly and carried out. Keeping the area cGMP compliant and acts as liaison during audits in production. Reviews and works with QA on raw material trending reports. Fills in for missing staff as needed in manufacturing, R&D, and packaging to ensure that production keeps moving and employee’s needs are met, this includes coordinating with other departments about their capabilities. Works to problem solve when issues arise that affect production or the compliance of production.

• Operator

  • Sep 2018 - Mar 2020

  Conduct and assist in the manufacturing process of pharmaceuticals. Keep all manufacturing areas clean and in compliance with FDA and company standards. Follow all SOP’s diligently. When necessary assist in other departments such as packaging or R&D. Experience with stainless steel jacketed kettles, mixers, ball valves and scales. Experience in writing investigations



Tapemark

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance Inspector

  • Aug 2015 - Aug 2018

  Inspected mainly pharmaceuticals and medical devices. Discarded and rejected products, materials and equipment that did not meet specifications. Recorded inspection and test data such as weights, temperatures, grades and quantities inspected. Monitored production operations for compliance with specifications and promptly reported defects. Collected samples during production and tested randomly to determine in-process product quality. Inspected and packaged products meticulously according to manufacturing specifications. Reviewing production records and in-process inspection. Experience in using IQS, SOP’s, ANSI. Experience with calipers, burst testers, and scales. Started training on pH meter and Viscometer operation and testing.