Data Maintenance & Reporting Coordinator in Piscataway, New Jersey at Kashiv Biosciences LLC

Position Summary

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

Data Maintenance & Governance
• 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.

Reporting & Analytics
• 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.

Cross-Functional Coordination
• 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.

Position Requirements and Qualifications

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.

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:

• Typing, desk work, and plant auditing.
• Must be able to read, write, and understand English.
• Manufacturing clean rooms. Some brief and/or minimal exposure to hazardous chemicals may occur, requiring personal protective equipment.
• Safety alertness is required due to working around hazardous equipment and conditions.
• General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines.

Supervisory Responsibility, if any: No

This position description is not a complete list of all responsibilities, duties, or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.

Kashiv BioSciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Kashiv BioSciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.