Quality Opertations Supervisor

Position Summary

This position collaborates with Praxis Leadership partners to educate, audit and enforce all applicable cGMPs, customer requirements, and Praxis QMS documents (while ensuring the same effectiveness and compliance within the Quality Operations group). Ensure compliance to requirements outlined in Praxis procedures and the FDA’s 21CFR Part 211.

Essential Functions and Responsibilities

• Ensure products meet quality and efficiency standards set by the company.
• Ensures Quality support and oversight packaging operations across multiple shifts, with the occasional weekend support for both facilities.
• Supports Work Order Compliance with batch record review/release.
• First responder problem solver with Quality issues.
• Supports Quality and Line Supervisors certification progress.
• Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits.
• Responsible for tracking and trending all Quality metrics related to packaging operations.
• Review, assess, approve non-conformance reports, including internal/external deviations, customer/consumer complaints, OOS/OOT investigations, incident reports, temperature excursions or any environmental/facility concerns.
• Supports agency, customer and vendor audits as needed.
• Apply Quality compliance principles to address a variety of issues and provide guidance on controlled documents, identifying gaps, RFT and continuous improvement initiatives.
• Responsible for adherence to all Company policies and procedures.
• Works to improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions.
• Instills a sense of quality through modeled quality behaviors and mindset.
• Supervises a diverse workforce.
• Aids in Training and Orientation. Ensures employees are trained according to their roles. Elevates complaints and problems, seeks Management assistance. Ensures proper PPE’s and Safety procedures are followed.
• Flexibly works other shifts, shifts may be 8, 10, or 12 hours as needed.
• Performs any other functions and duties assigned and necessary for the smooth and efficient operation of Praxis Packaging Solutions.