Job Description

Position Summary

The successful candidate will maintain and support the Quality Management System (QMS), including documents control, CAPA, change control, deviation management, and training records. Responsible for development and management of the Kashiv stability program in Piscataway.  The responsibility also includes collaboration on development and execution of stability protocols and SOPs related to the stability program. The candidate will be expected to work with IT and Purchasing to validate and implement a stability software program as required.   Support internal and external audits, including audit readiness, document preparation, tracking of findings, and ensuring timely closure of corrective actions. Assist with audits and analyze findings to support development and implementation of corrective and preventive actions (CAPAs). Ability to collaborate across multiple departments to drive timely resolution of projects, investigations, and process improvements is required.  The performance of general QC testing (release and stability) is also expected. The candidate will also be expected to ensure continuous coverage of the stability management and QMS function by selecting and training two individuals to be data verifiers of data entry and back up whenever absent. The position is also responsible for all aspects of the stability program.

Essential Duties & Responsibilities

• Initiating and completing deviations, handling the CAPAs, Change Controls and investigations associated to Quality Control activities.

• Monitor regulatory updates and industry trends; assist in implementing changes in procedures or systems as needed.

• Update the Quality Control documents as necessary in conjunction to the Regulatory requirements.

• Supported internal and external audit preparedness by maintaining inspection-ready GxP documentation, conducting compliance gap assessments, and coordinating timely resolution of audit observations

•  Manage and track QMS events, including deviations, nonconformances, investigations, change controls, and CAPAs, ensuring timely documentation and closure.

• Supported CAPA implementation and effectiveness verification to address recurring quality issues, strengthen compliance, and promote continuous improvement.

• Manage stability program for Kashiv Piscataway.

• Serve as QC point of contact for Quality Events

• Contributed to quality process improvements by identifying operational gaps, enhancing documentation controls, and supporting inspection readiness across regulated activities. 

• Train backup for role to ensure no disruption in stability program when absent.

• Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance. Maintain accurate and audit-ready records for both quality and regulatory activities, ensuring data integrity and adherence to ALCOA+ principles. Design, monitor, and analyze performance metrics to drive continuous quality improvement initiatives.

• Performs other functions as required or assigned.

• Complies with all company policies and standards.