Quality Management Systems Specialist

Amneal • Brookhaven, NY

12h

About The Position

The Quality Compliance 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
• Preparation of summary findings
• Support change controls
• Support planned deviations
• Support new product launch compliance
• Quality assurance trends analysis
• Review and approval of data
• Support preliminary investigations
• Support NOIs, CAPAs, Complaints and other Quality related activities and projects
• Audit tasks for reporting purposes
• Review change controls
• Review planned deviations
• Issue tasks
• Monitor due dates for tasks
• Follow-up on tasks
• Coordinate preparation, review and approval of NPLs
• Maintain and track commitments made to the agency
• Provide data analysis and insights to Senior Quality Management
• Propose corrective actions and improvements
• Collaborate with personnel from other functional areas
• Collect information
• Coordinate discussions for quality issue resolution
• Distribute associated documentation
• Act as a point of contact for external audits
• Maintain documentation supporting regulatory audits
• Audit Investigations and CAPA schedules
• Prepare, review and present/submit quality data with statistical approach
• Act as a subject matter expert for electronic QMS
• Notify QM management of activities impacting compliance or leading to regulatory action
• Prepare and/or ensure extension documentation is in place for delayed due dates

Nice To Haves

• Experience with electronic QMS

Responsibilities

• Reviews and approves (where applicable) respective data for the purpose of change, implementing, analyzing and reporting. The Associate 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.
• 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
• Provides Senior Quality Management with timely data analysis and insights to support compliance to the systems and Propose adequate corrective actions and applicable improvements .
• 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.
• Prepare, review and present/submit all quality data with statistical approach. Act as a subject matter expert for electronic QMS.
• 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.
• 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: Mid Level
• Education Level: No Education Listed