Senior Quality Management Systems Specialist

Job Description The Sr. Quality Management Systems Specialist provides coordination and reporting that includes data collection/generation, data analysis and data review and interpretation, and prepares summary findings to support change controls, planned deviations, new product launch compliance, and quality assurance trends related to various Quality Management processes. Essential Functions Reviews and approves (where applicable) respective data for change, implementing, analyzing and reporting. The Specialist collects/generates data for the purpose of analyzing and reporting, supports preliminary investigations, and prepares a summary of findings to support NOIs, CAPAs, Complaints and other quality related activities and projects. Regularly audits tasks completed for reporting purposes and identifies any possible outstanding actions for both sterile and non‑sterile quality operations. Reviews all change controls, planned deviations, provides approvals (where applicable), issues tasks, monitors due dates for associated tasks, and ensures necessary follow‑up activities are performed until all requested tasks have been completed and events are closed. Holds responsibility of coordinating preparation, review and approval process of NPLs (new product launches) within the required time frame. Maintains and tracks all commitments made to the agency as part of submissions for both sterile and non‑sterile quality operations. Prepares, reviews and presents/submits all quality data with a statistical approach. Acts as a subject matter expert for electronic QMS. Provides senior quality management leadership with timely data analysis and insights to support compliance with the systems and proposes 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 identified as unable to meet scheduled due dates due to ongoing activities. Collaborates 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. Acts 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 identifies any possible outstanding actions. Additional Responsibilities Assists with internal and regulatory audits as requested. Assists 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 relatable. Additional Requirement: Successful completion of an OSHA‑compliant respirator fit test. Salary & Benefits The base salary for this position ranges from $105,000 to $115,000 per year. Compensation will be determined based on qualifications, geographic location and other relevant factors. This includes above‑market, diverse and robust health and insurance benefits, a significant 401(k) matching contribution, and programs to promote employee well‑being. Equal Opportunity Employer 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. #J-18808-Ljbffr Amneal Pharmaceuticals