APARNA DODDI
Bridgeport,USA
Summary
Detail-oriented pharmaceutical professional with hands-on label control expertise. Proficient in ensuring compliance with FDA regulations and cGMP, while collaborating effectively with cross-functional teams to optimize label issuance and inventory management. Committed to maintaining operational excellence and continuous improvement in quality systems.
Overview
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1
Certification
Work History
Label Control Specialist
Essen Healthcare
New Jersey, USA
07.2026 - Current
- Support all Label Control activities for clinical and commercial manufacturing operations.
- Issue, inspect, reconcile, and control in-process and finished product labels.
- Verify label accuracy, artwork versions, batch numbers, lot numbers, expiry dates, and product information before release.
- Ensure compliance with FDA regulations, cGMP, Good Documentation Practices (GDP), and company quality standards.
- Perform label issuance and reconciliation following approved SOPs and work instructions.
- Coordinated with production, packaging, warehouse, planning, and quality assurance teams to ensure seamless manufacturing operations.
- Maintain label inventory records and monitor stock levels to prevent production delays.
- Review manufacturing batch records and packaging documentation prior to label issuance.
- Maintain accurate documentation in accordance with Good Documentation Practices.
- Support document control activities including issuance, revision, archival, and retrieval of controlled documents.
- Review and update Standard Operating Procedures (SOPs), forms, and work instructions.
- Support Change Control implementation and associated documentation.
- Participate in deviation investigations and root cause analysis.
- Assist in CAPA documentation and effectiveness verification.
- Support product complaint investigations by providing label history and documentation.
- Ensure compliance with ALCOA+ Data Integrity principles.
- Participate in qualification and validation activities related to labeling operations.
- Support internal audits, customer audits, and regulatory inspections.
- Assist Quality Assurance in maintaining compliance with FDA and company quality requirements.
- Performed periodic reconciliation of issued, returned, damaged, and obsolete labels to maintain accurate label inventory.
- Identified process improvement opportunities that reduced labeling errors and enhanced operational efficiency.
- Trained new employees on Label Control procedures and documentation practices. on Label Control procedures, documentation practices, and cGMP requirements.
- Ensure all labeling activities are completed accurately and within production schedules.
Program Data & Impact Analytics
Moral Injury Support Network for Service Women (MISNS)
North Carolina, USA
03.2026 - 06.2026
- Improved organizational datasets through collection, cleaning, validation, and maintenance.
- Performed quantitative and qualitative analysis to evaluate program outcomes.
- Created dynamic dashboards and comprehensive reports using Tableau and Microsoft Excel to visualize program performance.
- Generated KPIs and trend analysis reports for leadership.
- Supported monitoring, evaluation, and continuous improvement initiatives.
- Collaborated with cross-functional teams to improve reporting efficiency.
- Delivered analytical findings and actionable recommendations to stakeholders, enhancing decision-making.
Education
Master of Science - Business Analytics
Sacred Heart University
Fairfield, Connecticut05-2026
Bachelor of Business Administration -
Avinash College of Commerce
Hyderabad, IndiaSkills
- Label control
- Labeling Documentation
- Label Release Documentation
- Label Inventory Control
- Label reconciliation
- Label Control Audits
- Label Compliance Support
- Batch record review
- Batch verification
- Material verification
- GMP documentation
- cGMP compliance
- FDA Regulations
- Documentation practices
- SOP management
- Document control
- Change control
- CAPA management
- Deviation investigations
- Root cause analysis
- Data integrity
- Quality systems
- Quality Data Analysis
- Data Quality Assessment
- Microsoft Excel
- Tableau
- Data visualization
- SQL
- Python
- SAP S/4HANA
- Microsoft Word
- Microsoft PowerPoint
Certification
- SAP S/4HANA (Knowledge)
- Good Documentation Practices (GDP)
- Current Good Manufacturing Practices (cGMP)
- Microsoft Excel for Data Analytics
- Tableau Fundamentals
- SQL for Data Analysis
Projects
- Customer Churn Prediction Using Machine Learning, Python, SQL, Tableau, Excel, Logistic Regression, Decision Tree, Built predictive machine learning models with approximately 80% accuracy. Identified key customer churn factors using statistical analysis. Cleaned and transformed large datasets for predictive modeling. Designed Tableau dashboards to visualize customer behavior and churn trends. Presented business recommendations based on predictive analytics.
- Cirrhosis Liver Disease Analytics Dashboard, Tableau, Excel, Developed an interactive healthcare dashboard for patient analysis. Analyzed patient demographics and disease severity. Compared treatment outcomes using visualization techniques. Created KPI dashboards to support healthcare decision-making. Presented findings through interactive Tableau reports.
Timeline
Label Control Specialist
Essen Healthcare
07.2026 - Current
Program Data & Impact Analytics
Moral Injury Support Network for Service Women (MISNS)
03.2026 - 06.2026
Master of Science - Business Analytics
Sacred Heart University
Bachelor of Business Administration -
Avinash College of Commerce