Experience

Emergent BioSolutions

• United States
• Biotechnology Research
• 700 & Above Employee

• QA Shop Floor Supervisor

  • Apr 2021 - Present

  • Responsible for providing real-time Quality Assurance (QA) oversight during upstream and downstream operations of bulk drug substance (BDS) manufacturing. • Participated in work streams across multiple departments including Manufacturing, Quality Control (QC), and Engineering, Facilities, and Validation (EF&V) to ensure rigorous compliance with good manufacturing practices (GMP). • Collaborated with subject matter experts (SME) to address process deviations. Ensured a thorough evaluation of events was recorded in batch production records (BPR) and quality management systems (QMS) as necessary. • Performed real-time BPR review on the shop floor. Ensured that documents demonstrated a high standard of good documentation practices (GDP), aligned with ALCOA+ principles, conformed with data integrity requirements, and complied with governing standard operating procedures (SOP). • Authored QMS items including deviations, investigations, root cause analysis (RCA), corrective action/preventive action (CAPA), and effectiveness checks (EC). • Updated technical documents including SOPs, forms, logbooks, and reports as required per CAPA implementation or for general process improvements. • Performed review of corrective maintenance and corrective calibration work orders involving direct product impact systems. • Established rapport within and across departmental teams to drive an organizational culture shift towards an ethical and quality mindset. Show less



Takeda

• Japan
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Analyst

  • Jun 2013 - Apr 2021

  • Responsible for providing QA on the floor oversight of Formulation/Finishing manufacturing activities for Final Drug Products (FDP), including aseptic manufacturing within both restricted access barrier systems (RABS) and isolator filling lines. • Monitored filling activities and documented inherent and corrective interventions, and identified other non-qualified interventions for escalation, review, and proper corrective actions. • Qualified in aseptic cleanroom behavior and techniques involved in ISO Class 5/EU Grade A level areas. • Responsible for continuous development, preparation, and execution of the filling aseptic process simulation program (media fills) including intervention data analysis, and selection of simulation criteria. • Provided QA oversight during 100% visual inspection of final containers and during finishing (packaging) operations. Ensured batch acceptability through Acceptable Quality Limit (AQL) sampling and evaluation of ongoing finishing activities. • Responsible for issuing and reconciling product labels to finishing operations, ensuring physical and electronic inventory remained aligned. • Performed BPR review including process documentation, QC testing results, and acceptance for other batch release requirements, including clean-in-place (CIP) cycles, sterilization-in-place (SIP) cycles, and lyophilization drying cycles. • Responsible for authoring SOPs, BPRs, forms, and other documents per CAPA requirements or other process improvement initiatives. Collaborated both within and across departments to develop robust documents which meet the needs of internal and external customers. • Proficiency in the use of Microsoft Office applications including Word, Excel, and Powerpoint. • Considered a subject matter expert on multiple qualified procedures. Represented QA on the floor topics to auditors including the Food and Drug Administration (FDA). Show less



Take-Two Interactive

• United States
• Entertainment Providers
• 700 & Above Employee

• Quality Assurance Tester

  • Jun 2012 - May 2013

  ● Implemented testing procedures for multiple AAA video game titles. ● Identified any aspect from the user-end experience that diminished the product quality and reported each issue in clear detail to the development team. ● Used bug reporting software such as JIRA to communicate with development teams for further improvement of product. ● Verified bug fixes made with each version release were effective and did not produce additional unforeseen errors. ● Implemented testing procedures for multiple AAA video game titles. ● Identified any aspect from the user-end experience that diminished the product quality and reported each issue in clear detail to the development team. ● Used bug reporting software such as JIRA to communicate with development teams for further improvement of product. ● Verified bug fixes made with each version release were effective and did not produce additional unforeseen errors.



Drive Protected, LLC.

• Executive Assistant

  • Dec 2010 - Feb 2012