Senior Quality Management Systems Specialist

Amneal • Yaphank, NY

3h • $105,000 - $115,000

About The Position

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.

Requirements

• Data collection/generation
• Data analysis
• Data review and interpretation
• Prepare summary findings
• Support change controls
• Support planned deviations
• Support new product launch compliance
• Quality assurance trends
• Quality Management processes
• Review and approve data
• Support preliminary investigations
• Support NOIs, CAPAs, Complaints
• Audit tasks for reporting purposes
• Identify outstanding actions
• Review change controls
• Review planned deviations
• Issue tasks
• Monitor due dates
• Perform follow-up activities
• Coordinate preparation, review, and approval of NPLs
• Maintain and track commitments made to the agency
• Prepare, review, and present/submit quality data with statistical approach
• Act as a subject matter expert for electronic QMS
• Provide timely data analysis and insights to Senior Quality Management leadership
• Propose adequate corrective actions and applicable improvements
• Notify QM management of activities/decisions impacting site compliance
• Prepare extension documentation
• Collaborate with personnel from other functional areas
• Collect information
• Coordinate discussions to facilitate resolution of quality issues/concerns
• Distribute associated documentation
• Act as a point of contact for assigned responsibilities towards external audits
• Maintain concurrent documentation supporting regulatory audits
• Audit Investigations and CAPA schedules

Responsibilities

• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed