Quality Management System ( QMS ) Specialist

DescriptionVISA SPONSORSHIP NOT AVAILABLEThe Quality Assurance Quality Management System (QMS) Specialist is responsible for the maintenance of Kashiv BioSciences’ quality management system located in Piscataway, NJ. The role requires a thorough knowledge of laboratory practices, including testing and OOS investigations, and Quality Management Systems (QMS) such as Deviations, CAPAs, and Change Controls. This person will be responsible for ensuring that quality control and manufacturing operations have appropriate QA oversight in terms of the Quality Management System, including the identification and management of Nonconformances, OOS Investigations, and Deviations. The Quality Management System (QMS) Specialist will be expected to drive continuous improvement initiatives and be capable of assessing and improving existing systems. The incumbent will be responsible for Quality Management System functions of Quality Assurance, including providing guidance in support of both late-stage clinical and commercial biosimilar and novel Biologic products, cGMP-compliant laboratories, and manufacturing operations.The candidate needs to be highly motivated, well-organized, and detail-oriented Quality personnel who can work effectively in a fast-paced and multi-disciplinary environment.Essential Duties & ResponsibilitiesOversee thorough, timely, and compliant closure of Change controls, OOS investigations, Deviations, and CAPAs. Review progress and mentor department owners throughout the process to ensure the investigational process is logical, scientific, clear, and supported by evidence, and in compliance with company procedures.Ensure that all operations are compliant with cGMPs regulatory requirements.Write and review SOP system documents to ensure cGMP compliance, as required.Review the protocols and reports.Support regulatory inspections as a quality compliance representative.Monitor the effectiveness of Quality Systems, developing event metrics such as the number and type of batch record errors, training deviations, etc., and trend analysis for management review, escalate issues, and drive resolution.Ensure proper root-cause analysis and implement corrective and preventive actions.Plan and implement Quality Review Board meetings.Interface with all levels of the technical team to resolve issues.Perform other functions as required or assigned.Comply with all company policies and standards.RequirementsEducation:Bachelor's (required) /master’s degree in Life Science or other related discipline.Minimum of 7 years of relevant experience in a pharmaceutical quality assurance/control environment.Experience of GMP document review, Quality Management System maintenance.Understand the requirements and procedures related to document control and Quality Assurance.Experience working with electronic quality systems, preferred experience with Veeva and Master control, Blue Mountain RAM.Work Environment & Physical Demands: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:

YesBenefitsMedicalDentalVision401KCommuter/TransitStudent Loan AssistanceCell Phone AllowanceThis 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.

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