Quality Assurance Manager

RR Donnelley & Sons; Cudahy (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

RR Donnelley & Sons seeks a Quality Assurance Manager to oversee the site Quality Management System and advance quality standards.

You will lead audits, drive CAPA, and ensure compliance with GMP, ISO 9001 and 21 CFR Part 820 while coordinating with site management.

The role requires 5+ years in QA with at least 2 years in supervision, strong communication, and the ability to prioritize multiple initiatives.

Qualifications

• Bachelor's degree in a related field.
• Minimum 5+ years of QA experience with at least 2 years in supervisory roles.
• Advanced training or experience in cGMPs and ISO requirements.
• Ability to interpret federal regulations and apply to regulated products.
• Strong prioritization and multitasking skills with minimal supervision.
• Proficiency in Microsoft Office Suite.

Responsibilities

• Maintain and continually improve the site QMS and related processes.
• Coordinate ISO 9001:2008 and GMP audits and certification readiness.
• Lead and mentor quality staff and manage deviation investigations and CAPAs.
• Monitor quality metrics and report to Platform Quality Lead.
• Interface with customers on quality responses to RFPs/RFIs.
• Review GMP documents for compliance with SOPs and regulatory requirements.

Skills

Quality Assurance

Regulatory knowledge

Leadership

GMP/cGMPs understanding

Documentation & reporting

Education

Bachelor's Degree in Related Field

Tools

Microsoft Office

Job description

Company Description

RRD provides marketing, packaging, print, and business services to the world's most respected brands. The company's proprietary technology, advanced data analytics, and expertise fuel organizational decision-making from strategy through execution, delivering sustainable solutions with the lowest possible environmental impact. Global organizations and regulated industries trust RRD to reduce complexity and drive audience connections across the entire customer journey.

Job Description

RRD is seeking a Quality Assurance Manager to oversee and advance our quality systems and standards!

Job Summary

The Quality Manager will oversee the implementation, maintenance and continuous improvement of the site Quality Management System and Quality Metrics performance. He/She will work with site management and personnel to plan, develop, implement and continually improve site relevant QMS requirements, and to ensure sustainable compliance to customer, regulatory and RR Donnelley QMS requirements.

Responsibilities

• Provides ongoing leadership and support in maintaining and continually improving of site Quality Management System (QMS) and processes inclusive of food safety / contact & Medical Device / Pharma GMP's, as required.
• Ensures that site QMS is in compliance with RRD QMS requirements, including Quality Task Tracker and Quality Metrics reporting.
• Coordinates activities to maintain relevant Quality System requirements such as ISO 9001:2008, GMP (21 CFR Part 820), etc., including preparing for and scheduling annual certification compliance audits.
• Informs site Management of significant or potentially significant quality issues, and facilitates effective root cause analysis and corrective/preventive actions to reduce or eliminate errors.
• Monitors and measures trends in QMS processes, including GMP Quality Metrics.
• Evaluates the effectiveness of relevant site QMS processes (such as ISO 9001:2008, GMP (21 CFR Part 820)) through internal audits and the evaluation of site Quality Metrics data.
• Collects and submits quality task tracker and quality metrics data for the site, on a monthly basis, and issues a report to the Platform Quality Lead
• Interacts with customers and assists with quality related responses to RFP's/RFI's for the site.
• Reviews relevant GMP documents for compliance to company SOPs, quality systems, and regulatory requirements.
• Leads and manages ongoing internal process verification audits throughout year.
• Provides leadership and direction to quality department employees.
• Ensures all deviation investigations are appropriately investigated and recorded.
• Drives CAPA items to complete and timely completion.
• Participates in other activities, as deemed appropriate.

Qualifications

• Minimum:4 Year / Bachelors Degree in Related Field
• Minimum 5+ years related work experience including a minimum of 2 years of supervisory experience.
• Advanced training or experience in cGMPs, and ISO required.
• Ability to understand and interpret federal regulations and company operating procedures as they apply to printing regulated product and quality issue..
• Must be able to prioritize and multi-task with minimal supervision.
• Knowledge of PC systems and Microsoft Office Suite (Word, Excel) required.
• Excellent written and verbal communication skills.

Additional Information

RRD is an Equal Opportunity Employer, including disability/veterans

At RRD, we value innovation, authenticity, and integrity. To uphold the security and fairness of our hiring process, we ask that candidates refrain from using AI tools during interviews to ensure an authentic and secure experience. We appreciate your cooperation as we work to maintain a transparent and equitable hiring process.

All employment offers are contingent upon the successful completion of both a pre-employment background and drug screen.