Firas Sofyan

About Firas Sofyan

I am a knowledgeable and resourceful technologist known for ensuring accurate and timely delivery of results in fast-paced environments. I am detail orientated with experience in various laboratory testing methodologies, equipment, and clinical significance. Strong academic and laboratory qualifications including Microbiology experience in a Pharmaceutical setting and Molecular testing within a clinical setting. I am proficient in presentation and communication skills and working within a close-knit team that is focused on collaboration, completion of experimental deadlines, and focus on increased productivity.Competencies: Analytical/Assessment Skills, Communication Skills, Cultural Competency Skills, Quality Control/Assurance, and Laboratory Skills.

Experience

1. Associate Ii Quality Assurance

   Resilience

   Aug 2024 — Present · West Chester, OH, US

   Maintain a high level of understanding of relevant production processes and quality systems • Perform the QA review and approval of the following GMP documentation that has a direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable: o Change Requests o Batch Records and associated documentation o Product and Component Release transactions in SAP o Quality Investigations (Deviations, Product Complaints) o Validation Plans, Protocols, and Reports o Standard Operating Procedures • Collaborate with and influence other Quality professionals across the organization to ensure consistent application and execution of key quality systems • Execute QA processes including batch record review, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectives • Interface with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects • Collaborate with and influence other PET/assigned area members to facilitate process improvements and risk assessments; benchmark internal and external QA practices to identify innovative efficient and effective practices• Stay abreast of evolving regulatory compliance practices and recommend implementation strategies to site leaders • Collaborate in data analysis and report creation on quality metrics and key performance indicators

Education

• Eastern Kentucky University

  Master of Public Health - MPH

  2020 — 2023

• University of Kentucky

  Bachelor of Science - BS

  2014 — 2018