Shanell Arakua

Quality Assurance and Administrative professional with 3 years of experience supporting regulated operations, documentation, inspections, and production activities. Experienced in batch record review, deviation tracking, CAPA support ERP/MES data accuracy, and cGMP documentation. Provides reliable administrative and operational support that strengthens compliance, documentation accuracy, and production readiness.

Skilled at coordinating cross-functional activities and maintaining audit-ready records

Quality Assurance Specialist at Cardinal Health (2025-11 – 2026-05)

• Performed in-process quality inspections and environmental monitoring, including ATP swabs, temperature checks, sanitation verification, and hygiene audits across production and packaging areas.
• Reviewed batch records, packaging documentation, and quality logs for completeness, accuracy, and compliance with established SOPs.
• Collaborated with Quality and Production leadership to investigate deviations, identify root causes, and implement corrective and preventive actions (CAPA).
• Verified calibration status of critical equipment, including balances, torque testers, and probes, before production use and reported discrepancies for follow-up.
• Maintained consistent quality oversight and supported production requirements during periods of increased operational demand.

Administrative Assistant at Brickyard (2023-08 – 2025-06)

• Prepare reports, meeting agendas, and other administrative documentation
• Support multiple departments with administrative projects while consistently meeting deadlines
• Maintain spreadsheets, databases, and internal records with a high degree of accuracy.
• Maintain organized electronic and paper filing systems while ensuring document accuracy and confidentiality.
• Assisted with daily office operations and responded to requests from staff and management.

Quality Assurance Specialist at Granules Pharmaceuticals (2022-02 – 2024-11)

• Investigated supplier deviation involving Certificates of Analysis (CoA), damaged materials, and incorrect lot documentation, and worked with suppliers to resolve discrepancies.
• Maintained accurate ERP/MES records for material movements, lot tracking, product traceability, and production reporting.
• Reviewed batch documentation, quality checklists, and deviation records for completeness and accuracy prior to product release.
• Performed in-process and final quality inspections of medical devices and pharmaceutical packaging to verify compliance with established specifications.

Admin Assistant at ADT Security (2020-09 – 2022-02)

• Provided administrative support to field technicians and office staff in a fast-paced environment.
• Coordinated communication among technicians, management, and customers to support timely completion of service requests.
• Performed data entry, filing, email correspondence, and report preparation
• Demonstrated strong organizational, multitasking, customer service, and communication skills
• Maintained strong organization, communication, and multitasking skills while managing competing administrative priorities.

Bachelor of Science in Business Information Technology – Northern Virginia Community College