Oct 2021 – Feb 2022 · 4 mos · Bedford Heights, Ohio, United States · On-site

• Documentation and Regulatory Auditing: Performed comprehensive final auditing and reconciliation of Batch Production Records (BPRs) and Quality Control data (CoA), ensuring strict compliance with GMP and regulatory mandates (e.g., 21 CFR Part 11).
• Quality System Management and End-User Resolution: Managed key quality systems (e.g., CAPAs) and drove the analytical resolution of documentation discrepancies and minor deviations with manufacturing teams. Created and distributed targeted end-user documentation and training materials to personnel
• Systems Design and Process Automation: Utilized visualization and automation platforms (e.g., Power Automate) to design and implement streamlined workflows for documentation control (e.g., BPR distribution) and managing interdepartmental service requests.
• Documentation Control and QMS Administration: Owned the Quality Management System (QMS) documentation lifecycle by reviewing, editing, and archiving Standard Operating Procedures (SOPs) and providing critical batch record support during internal and regulatory inspection audits.

Sep 2020 – Oct 2021 · 1 yr 1 mo · Bedford Heights, Ohio, United States · On-site

• Real-Time Aseptic and Operational Oversight: Served as the dedicated QA authority on the manufacturing floor, conducting visual audits on personnel performing aseptic techniques and executing real-time line clearances to ensure strict adherence to GMP, SOPs, and Master Batch Records (MBRs).
• Integrated Deviation Management & Quality Training: Served as the first responder for deviations, initiating formal investigations, and driving resolution through the documentation of corrective/preventive actions (CAPAs); developed and delivered SOP-driven training programs and end-user documentation (e.g., real-time deviation guides) to manufacturing personnel, ensuring immediate and accurate adherence to quality systems and GMP standards.
• Process Automation and Systems Analysis: Utilized visualization and automation platforms (Power Automate/Excel) to design and implement custom tracking systems and notification tools, enhancing departmental process control and efficiency.
• Document Control and Compliance Auditing: Owned the Quality Management System (QMS) documentation by reviewing and editing Standard Operating Procedures (SOPs) to maintain current quality standards; performed comprehensive audits of critical control items, including finished medicine and validation documentation.

Sep 2018 – Aug 2020 · 1 yr 11 mos · Akron, Ohio, United States · On-site

• Multi-Site Patient Flow and Communication: Managed patient intake, scheduling, and communication across three different office locations, serving as the primary hub for appointments and follow-up for patients seeking to reestablish care.
• Advanced Health Information Systems (EPIC): Maintained strict HIPAA compliance while managing and processing comprehensive patient medical records, referrals, and administrative paperwork directly within the EPIC Electronic Health Record (EHR) system.
• Research and Financial Administration Support: Supported clinical activity by documenting initial medicine research data for an onsite physician and processing all required financial administration, including complex insurance eligibility verification and co-payment collection.

Jun 2017 – May 2018 · 11 mos · Kent, Ohio, United States · On-site

• Contributed to the "Epidemiology of Staphylococcus aureus and Streptococcus" study, which resulted in the two publications listed in your resume.
• Conducted research to assess the diversity and abundance of Staphylococcus aureus in U.S. livestock, and to investigate the molecular epidemiology and antibiotic resistance of Streptococcus pyogenes isolates in Mongolia.

Mar 2017 – Aug 2017 · 5 mos · Kent, Ohio, United States · On-site

• • Supported the "Neuro Humanistic Research & Methodological Pursuit of Lived Experience: An EEG Study" by assisting with data collection and analysis.

Sep 2016 – Mar 2017 · 6 mos · Kent, Ohio, United States · On-site

• • Assisted with the "Transgender Women’s Daily Life Experiences Study" by supporting qualitative data collection and organization.