The Quality Assurance Quality Management System ( QMS ) Specialist is responsible for maintenance of the 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 Quality Management System, including 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 & Responsibilities

• Oversee 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.
• Reviews the protocols and reports.
• Supports regulatory inspections as a quality compliance representative.
• Monitors effectiveness of Quality Systems, developing event metrics such as number and type of batch record errors, training deviations, etc., and trend analysis for management review, escalates issues and drives resolution.
• Ensure proper root-cause analysis and implement corrective and preventive actions.
• Planning and implementation of Quality Review Board meetings.
• Interface with all levels of technical team to resolve issues.
• Performs other functions as required or assigned
• Complies with all company policies and standards

Requirements

Education:

• Bachelor (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 system, preferred experience with Veeva and Master control, Blue Mountain RAM

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