Quality Specialist (QMS Investigator)

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.

Education:

• 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.

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

The salary range for this position ranges from $70,000 - $95,000 per year. In addition, Kashiv BioSciences, LLC., offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Kashiv BioSciences, LLC., ranges reflect the Company’s good faith estimate of what Kashiv BioSciences, LLC., reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.

At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.