Experience

Exela Pharma Sciences LLC

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• QC Microbiology Manager

  • Oct 2022 - Present

• Sterility Assurance Technician

  • Aug 2021 - Oct 2022



Baxter International Inc.

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Quality Lab Associate III

  • Sep 2019 - Aug 2021

  - Environmental Monitoring Performance Qualifications (EMPQ) including risk assessments to provide documented evidence of cleanroom classification. - Environmental FMEA, Touch-Point Analysis, Traffic Flow Analysis, Historical Data Trends - Instructor of contamination control for new hires to the facility. - Environmental Monitoring Performance Qualifications (EMPQ) including risk assessments to provide documented evidence of cleanroom classification. - Environmental FMEA, Touch-Point Analysis, Traffic Flow Analysis, Historical Data Trends - Instructor of contamination control for new hires to the facility.

• QC - Microbiology Supervisor

  • Aug 2018 - Sep 2019

  - Supervision of a microbiology laboratory and environmental monitoring (EM) program for a sterile manufacturing facility - Designed a new microbiology laboratory including functionality, material flow, and equipment usage - Manage planning, scheduling, and training for a quality control team of fifteen employees - Implemented new protocols and Standard Operating Procedures (SOPs) to improve overall quality testing - Reviewer of all documentation for Quality Control (QC)… Show more - Supervision of a microbiology laboratory and environmental monitoring (EM) program for a sterile manufacturing facility - Designed a new microbiology laboratory including functionality, material flow, and equipment usage - Manage planning, scheduling, and training for a quality control team of fifteen employees - Implemented new protocols and Standard Operating Procedures (SOPs) to improve overall quality testing - Reviewer of all documentation for Quality Control (QC) Microbiology - Escort FDA auditors through QC Microbiology areas and documentation during audit periods

• Microbiologist II

  • Sep 2016 - Aug 2018

  - Quality documentation such as Deviations, Corrective and Preventative Actions (CAPAs), SOPs, Trending Summaries of all Environmental Monitoring Data, Quarterly Reports, and Change Controls - Coordination of all laboratory inventory with outside vendors - Training/scheduling of new employees as the senior microbiologist

• Microbiologist I

  • Dec 2015 - Sep 2016

  - EM of ISO class 5-8 cleanrooms including swabbing techniques in a manufacturing environment - QC Testing such as Bioburden, Endotoxin, Biological Indicator, Indicator Organism, & Sterility Testing - Gram Staining/Bacterial & Fungal Identification - Total Organic Carbon and Conductivity Testing of Water for Injection (WFI) - Execution of Method Validations for new products - Out-of-Trend and Out-of-Specification Investigations - Growth Promotion… Show more - EM of ISO class 5-8 cleanrooms including swabbing techniques in a manufacturing environment - QC Testing such as Bioburden, Endotoxin, Biological Indicator, Indicator Organism, & Sterility Testing - Gram Staining/Bacterial & Fungal Identification - Total Organic Carbon and Conductivity Testing of Water for Injection (WFI) - Execution of Method Validations for new products - Out-of-Trend and Out-of-Specification Investigations - Growth Promotion Testing of Media including inoculation with ATCC organisms - Operation of an Autoclave - Conduct internal audits to ensure conformance to Code of Federal Regulations (CFR) & SOPs - Used Aseptic Technique in Laminar Flow Hoods for testing of microorganisms

• Quality Assurance Officer

  • Jun 2014 - Dec 2015

  - Oversight of the Labeling/Packaging & Inspection areas to ensure activities were aligned with current Good Manufacturing Practices (cGMPs) - Ensured legibility and quality of final packaged drug product (vials, cartons, labels, package insert) - Ensured rejected product and components were disposed of in a timely manner - Reviewed batch production records - Worked with Quality Assurance Management to complete Investigation Reports and Deviation Reports - Incoming Raw Material… Show more - Oversight of the Labeling/Packaging & Inspection areas to ensure activities were aligned with current Good Manufacturing Practices (cGMPs) - Ensured legibility and quality of final packaged drug product (vials, cartons, labels, package insert) - Ensured rejected product and components were disposed of in a timely manner - Reviewed batch production records - Worked with Quality Assurance Management to complete Investigation Reports and Deviation Reports - Incoming Raw Material Inspection (IRMI)



RTI International

• United States
• Research Services
• 700 & Above Employee

• Keyer/Coder

  • Sep 2013 - May 2014

  - Worked with a team to complete educational longitudinal studies - Transferred hard copy data into an online-database system - Handled confidential material that required successfully passing a background check - Worked with a team to complete educational longitudinal studies - Transferred hard copy data into an online-database system - Handled confidential material that required successfully passing a background check