Senior Quality Management Systems Specialist

View More Jobs Senior Quality Management Systems Specialist Brookhaven, NY, United States Job Description Description:

The Sr. Quality Management Systems Specialist provides coordination and reporting that includes data collection/generation, data analysis and data review and interpretation. In addition, prepares summary findings to support change controls, planned deviations, new product launch compliance, as well as quality assurance trends related to various Quality Management processes.

Essential Functions:

Reviews and approves (where applicable) respective data for the purpose of change, implementing, analyzing and reporting. The Specialist collects / generates data for the purpose of analyzing and reporting. Additionally, supports preliminary investigations and prepares a summary of the findings to support NOIs, CAPAs, Complaints and other Quality related activities and projects. Regularly audits the tasks completed for reporting purposes and identification of any possible outstanding actions for both Sterile and Non-Sterile Quality Operations Reviews all change controls, planned deviations, provide approvals (where applicable), issues tasks, monitor due dates for the associated tasks ,necessary follow-up activities are performed until all requested tasks have been completed and events are closed. Holds the responsibility of coordinating in preparation, review and approval process of NPLs (New Product Launches) within the required time frame. Maintain, track all commitments made to the agency as part of submissions for both Sterile and Non-Sterile Quality Operations Prepare, review and present/submit all quality data with statistical approach. Act as a subject matter expert for electronic QMS. Provides Senior Quality Management leadership with timely data analysis and insights to support compliance to the systems and Propose adequate corrective actions and applicable improvements . Notifies QM management of any activities or decisions that may impact the compliance of the sites that may lead to regulatory action. Prepares and/or ensures that extension documentation are in place for those which have been identified as unable to meet the scheduled due dates due to ongoing activities. Will collaborate with personnel from other functional areas to collect information and coordinate discussions to facilitate the resolution of quality issues/ concerns and distribute associated documentation as applicable. Act as a point of contact for assigned responsibilities towards external audits. Maintaining required concurrent documentation supporting regulatory audits. Regularly audits the Investigations and CAPA schedules for reporting purposes and identification of any possible outstanding actions.

Additional Responsibilities:

Assist with internal and regulatory audits as requested. Assist with analyzing, displaying and customizing data reports in formats such as scorecards and presentations on a bi-weekly, monthly and quarterly basis.

Qualifications Education:

Bachelors Degree (BA/BS) Related QA Experience for Sterile & Non-Sterile Ops -

Required Experience:

4 years or more in

Related QA Field Experience Specialized Knowledge:

Organized, creative and the ability to communicate thoughts and ideas clearly. Able to present data and trends in a manner that is easily understood and is relatable.

Additional Requirement:

This position requires successful completion of an OSHA-compliant Respirator Fit Test. The base salary for this position ranges from $105,000 to $115,000 per year. Amneal ranges reflect the Company's good faith estimate of base salary that Amneal 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, 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 helps you enjoy your career alongside life's many other commitments and opportunities. Required Skills Change Control Data Reporting Facility Inspection Good Manufacturing Practices

ISO 9000

Series Process Improvement Quality Management Systems Regulatory Compliance Risk Management Root Cause Analysis Statistical Process Controls Strategic Decision Making Workflow Management About Us Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws. Apply Now Job Info Job Identification 7992 Job Category Quality Management Systems Posting Date 05/18/2026, 09:00 AM Locations 50 Horseblock Road, Brookhaven, NY, 11719, US Job Schedule Full time © MapTiler © OpenStreetMap contributors Legend Jobs at a location Group of locations © MapTiler © OpenStreetMap contributors | © Oracle Corporation Terms Legal Notices Use control and scroll to zoom the map Use two fingers to move the map 50 Horseblock Road, Brookhaven, NY, 11719, US Copy to Clipboard Similar Jobs Associate Director, Revenue Management Bridgewater, NJ, United States Posted on 04/22/2026 The overall responsibilities of the Associate Director, Revenue Management are to provide direction, management, training to the department in relation to department projects and new business assignments. Manager, Quality - Sterile Operations Brookhaven, NY, United States Posted on 04/20/2026 Trending The Sterile

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