Quality Specialist (QMS Investigator)

Position Summary

Maintain and support the Quality Management System (QMS), including document control, CAPA, change control, deviation management, and training records. Responsible for development and management of the Kashiv stability program in Piscataway, including collaboration on development and execution of stability protocols and SOPs. Work with IT and Purchasing to validate and implement a stability software program. Support internal and external audits, including audit readiness, document preparation, tracking of findings, and timely closure of corrective actions. Assist with audits and analyze findings to support development and implementation of CAPAs. Collaborate across multiple departments to drive timely resolution of projects, investigations, and process improvements. Perform general QC testing (release and stability). Select and train two individuals to be data verifiers of data entry and back up whenever absent.

Essential Duties & Responsibilities

• Initiate and complete deviations, handle CAPAs, change controls, and investigations associated with Quality Control activities.
• Monitor regulatory updates and industry trends; assist in implementing changes in procedures or systems as needed.
• Update Quality Control documents as necessary in conjunction with regulatory requirements.
• Support 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.
• Support 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.
• Contribute 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.
• 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.
• Perform other functions as required or assigned.
• Comply with all company policies and standards.

Qualifications

Bachelor's degree in biotechnology, biochemistry, chemistry, or related field with experience in QMS activities along with stability program handling with a minimum of 6-8 years of experience in a pharmaceutical/biotech QC laboratory. Alternatively, Master's degree in above areas/M Pharmacy in pharmaceutical Analysis with 4 years of experience in a pharmaceutical/biotech QC laboratory or PhD in above areas with a minimum of 2 years of experience.

Previous experience in a cGMP laboratory. Demonstrated success at writing, revising, and complying with SOPs, protocols/reports, and QC methods. Experience with OOS and Laboratory Investigations, Deviations, Change Controls and CAPAs.

Special Skills

• Ability to work with minimal supervision.
• Ability to work well under pressure and adapt to change as needed.
• General understanding of medical terminology, clinical trials, and drug development process.
• Strong organizational skills and ability to prioritize multiple projects and meet deadlines.
• High degree of fluency in written and spoken English.
• Excellent interpersonal and communication skills.
• Ability to establish and maintain professional and productive working relationships.
• Proficiency with computer applications (e.g., Adobe Acrobat, MS Word, MS Excel, MS PowerPoint).

Work Environment & Physical Demands

Significant amount of time spent in an office doing office work (reading, writing, reviewing, and editing documents). Some amount of time spent in the laboratory. Must be able to work extended hours or weekend hours as requested. Ability to work under pressure and meet deadlines. High-paced environment structured to meet ambitious project goals. Minimal travel required.