Data Maintenance & Reporting Coordinator
Kashiv BioSciences LLC · Piscataway, NJ · 5 days ago
FinanceFull-time
Description
The Data Maintenance & Reporting Coordinator will support Manufacturing Science & Technology (MSAT) operations by ensuring the integrity, accuracy, and timely availability of manufacturing, quality, and process-related data. This role is responsible for maintaining critical datasets, performing data validation and reconciliation activities, generating reports and dashboards, and supporting cross-functional teams with data-driven insights. The successful candidate will collaborate closely with MSAT, Quality Control (QC), Manufacturing, and other stakeholders to ensure data consistency, traceability, compliance, and reporting excellence in a GMP-regulated environment.
Essential Duties & Responsibilities
- Maintain and manage QC, manufacturing, and process datasets to ensure accuracy, completeness, and consistency across systems.
- Perform routine data cleansing, validation, reconciliation, and quality checks.
- Investigate and resolve data discrepancies while ensuring proper documentation and traceability.
- Maintain data repositories, trackers, logs, and documentation in accordance with company procedures and regulatory requirements.
- Support data integrity initiatives and compliance with ALCOA+ principles and GMP requirements.
- Consolidate data from multiple sources, including QC and manufacturing test results, manufacturing batch records, process monitoring systems, and project trackers.
- Generate routine and ad hoc reports for MSAT, Manufacturing, Quality, and leadership teams.
- Develop and maintain dashboards to monitor process performance, yield trends, quality metrics, CAPAs, deviations, OOS/OOT investigations, and other operational KPIs.
- Support periodic reporting activities, including Product Performance Qualification (PPQ) reporting and process monitoring summaries.
- Analyze trends and assist stakeholders in identifying risks, opportunities, and areas for process improvement.
- Collaborate with MSAT, QC, Manufacturing, Quality Assurance, and external stakeholders to gather and validate required data.
- Participate in stakeholder meetings and document key discussions, decisions, and action items.
- Support project leads by maintaining activity trackers, status reports, and deliverable timelines.
- Provide timely updates and communicate data-related issues, risks, and recommendations to stakeholders.
- Serve as a liaison between technical teams and business functions regarding reporting and data requirements.
Key Deliverables
- Clean, validated, and reliable datasets for MSAT and business operations.
- Periodic MSAT performance and compliance reports.
- Dashboards supporting process monitoring and quality oversight.
- Accurate tracking and reporting of manufacturing and QC metrics.
- Timely identification and escalation of data discrepancies, trends, and risks.
- Documentation supporting regulatory compliance and audit readiness.
Requirements
- Experience 3–5+ years of experience in data coordination, reporting, research operations, project administration, technical documentation, or related functions.
- Experience collecting, organizing, validating, and analyzing quantitative and qualitative data from multiple sources.
- Experience generating reports, presentations, dashboards, tables, graphs, and management summaries.
- Strong proficiency with Microsoft Excel, data tracking tools, and reporting systems.
- Experience coordinating activities across multiple stakeholders and managing project documentation.
- Strong attention to detail, accuracy, and organizational skills.
Preferred Qualifications
- Experience supporting research, healthcare, public health, pharmaceutical, life sciences, or regulated-industry initiatives.
- Experience with survey tools, analytics platforms, and performance reporting.
- Understanding of data governance, documentation control, and quality management principles.
- Familiarity with process improvement, workflow management, and stakeholder communications.
- Technical background in software, systems, or database-related environments.
- Ability to quickly learn GMP, ALCOA+, and pharmaceutical compliance requirements.