Quality Assurance Manager
About The Position
RRD is seeking a Quality Assurance Manager to oversee and advance the site’s quality systems and standards. The role oversees implementation, maintenance, and continuous improvement of the site Quality Management System (QMS) and Quality Metrics performance. Working with site management and personnel, the Quality Manager plans, develops, implements, and continually improves site-relevant QMS requirements to ensure sustainable compliance with customer, regulatory, and RR Donnelley QMS requirements. The role 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
- Provide leadership and support to maintain and continually improve the site QMS and processes, including food safety/contact and Medical Device/Pharma GMP requirements as applicable.
- Ensure the site QMS complies with RRD QMS requirements, including Quality Task Tracker and Quality Metrics reporting.
- Coordinate activities to maintain relevant quality system requirements, such as ISO 9001:2008 and GMP (21 CFR Part 820), including preparation for and scheduling of annual certification compliance audits.
- Inform site management of significant or potentially significant quality issues and facilitate root cause analysis and corrective/preventive actions.
- Monitor and measure trends in QMS processes, including GMP Quality Metrics.
- Evaluate the effectiveness of site QMS processes through internal audits and evaluation of site Quality Metrics data.
- Collect and submit site quality task tracker and quality metrics data monthly, and issue reports to the Platform Quality Lead.
- Interact with customers and assist with quality-related responses to site RFPs/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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
