Nadia Bila
Cincinnati,OH
Summary
Detail-oriented Quality Control Analyst with extensive experience in GMP-regulated pharmaceutical environments and a strong focus on Quality Assurance activities, including batch record review, deviation investigations, and documentation control. Expertise in ensuring compliance with cGMP, FDA regulations, and data integrity principles (ALCOA+) while supporting product quality and driving process improvements. Skilled in fostering cross-functional collaboration to uphold quality systems, facilitate audits, and implement continuous improvement initiatives that enhance operational efficiency and product reliability. Committed to maintaining the highest standards of quality assurance in every aspect of the role.
Overview
13
13
years of professional experience
Work History
Quality Control Analyst I
Teva Pharmaceuticals
02.2023 - Current
- Managed adherence to CGMP, USP, and FDA regulations to maintain high standards of laboratory integrity and quality assurance.
- Perform QA-relevant review of laboratory documentation, including analytical test records, solution preparations, and electronic data in LabWare, ensuring accuracy, completeness, and data integrity (ALCOA+).
- Conducted thorough reviews of batch records, confirming that analytical results and documentation align with established quality and regulatory criteria.
- Led deviation investigations (OOS/OOT) to identify root causes and implement corrective action plans.
- Facilitated cross-functional collaboration with QA, QC, and manufacturing teams to drive product disposition decisions.
- Conducted evaluations of SOPs and test methods, ensuring all controlled documents met regulatory compliance criteria.
- Execute and support validation activities, including testing for validation protocols and ensuring proper documentation practices.
- Utilize LIMS (LabWare) and Empower systems for data management, ensuring compliance with electronic data integrity standards.
- Support audit readiness and inspection activities by maintaining accurate and compliant documentation.
Warehouse Associate
Amazon
08.2016 - 02.2023
- Performed thorough quality assessments and process validations to guarantee adherence to operational standards and product integrity.
- Facilitated continuous improvement initiatives to optimize workflow efficiency and uphold safety standards.
Research Assistant, Oncology Department
Cincinnati Children’s Hospital
06.2020 - 07.2022
- Maintained detailed and compliant laboratory documentation and data records, ensuring traceability and accuracy.
- Supported protocol-driven research activities, ensuring adherence to established procedures and quality standards.
- Assisted in training and mentoring staff, reinforcing standard operating procedures and compliance practices.
Direct Support Professional
ViaQuest
01.2018 - 11.2020
- Monitored and recorded patient data with high attention to detail and accountability.
Packaging Technician
Tobinco Pharmaceuticals
01.2013 - 12.2013
- Operated pharmaceutical packaging equipment in compliance with GMP standards.
- Ensured proper labeling and packaging of products to meet quality requirements.
Education
Bachelor of Science - Biology
University of Cincinnati
Cincinnati, OH05.2020
Skills
- CGMP Compliance & FDA Regulations
- Batch Record Review & Product Disposition Support
- Deviation Investigations & CAPA
- Change Control & Documentation Management
- SOP Review & Development
- Validation Documentation (Protocols, Reports)
- Data Integrity (ALCOA)
- Quality Systems & Risk Assessment
- Audit Preparation & Regulatory Support
- LIMS (LabWare), Empower, SAP (exposure if applicable)
- Analytical Testing (HPLC, UV-Vis, KF, Dissolution, etc)
- Cross-functional Collaboration & Process Improvement
Timeline
Quality Control Analyst I
Teva Pharmaceuticals
02.2023 - Current
Research Assistant, Oncology Department
Cincinnati Children’s Hospital
06.2020 - 07.2022
Direct Support Professional
ViaQuest
01.2018 - 11.2020
Warehouse Associate
Amazon
08.2016 - 02.2023
Packaging Technician
Tobinco Pharmaceuticals
01.2013 - 12.2013
Bachelor of Science - Biology
University of Cincinnati