Quality Assurance Manager

RR Donnelley • Cudahy, WI

3d

About The Position

RRD is seeking a Quality Assurance Manager to oversee and advance the site’s quality systems and standards. The role is responsible for implementing, maintaining, and continuously improving the site Quality Management System (QMS) and quality metrics performance. The Quality Manager works with site management and personnel to plan, develop, implement, and improve site-relevant QMS requirements, ensuring sustained compliance with customer, regulatory, and RRD QMS requirements. The position also provides leadership and direction to quality department employees and interacts with customers on quality-related matters.

Requirements

• Bachelor’s degree in a related field.
• At least 5 years of related work experience, including at least 2 years of supervisory experience.
• Advanced training or experience in cGMPs and ISO.
• Ability to understand and interpret federal regulations and company operating procedures as they apply to printing regulated products and quality issues.
• Ability to prioritize and multitask with minimal supervision.
• Knowledge of PC systems and Microsoft Office Suite, including Word and Excel.
• Excellent written and verbal communication skills.

Responsibilities

• Lead and support the maintenance and continuous improvement of the site QMS and processes, including food safety, contact, and Medical Device/Pharma GMPs as required.
• Ensure the site QMS complies with RRD requirements, including Quality Task Tracker and Quality Metrics reporting.
• Coordinate activities to maintain applicable quality-system requirements, including ISO 9001:2008 and GMP (21 CFR Part 820), and prepare for and schedule annual certification compliance audits.
• Inform site management of significant or potentially significant quality issues and facilitate root cause analysis and corrective and preventive actions.
• Monitor and measure trends in QMS processes, including GMP Quality Metrics.
• Evaluate site QMS process effectiveness through internal audits and quality metrics data.
• Collect and submit site quality task tracker and metrics data monthly, and report the results to the Platform Quality Lead.
• Interact with customers and assist with quality-related responses to RFPs and RFIs.
• Review relevant GMP documents for compliance with company SOPs, quality systems, and regulatory requirements.
• Lead and manage ongoing internal process verification audits throughout the year.
• Provide leadership and direction to quality department employees.
• Ensure deviation investigations are appropriately investigated and recorded.
• Drive CAPA items to timely completion.
• Participate in other activities as deemed appropriate.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager