Quality Assurance Leader - GMP/ISO Compliance

RR Donnelley; Cudahy (CA); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

RR Donnelley in California is seeking a Quality Assurance Manager to oversee the site Quality Management System and drive continuous improvement of quality performance.

You will partner with site leadership to ensure regulatory and customer requirements are met, coordinate ISO 9001:2008 and GMP practices, lead CAPA investigations and audits, and mentor the quality team to sustain robust metrics and a culture of quality.

Qualifications

• Minimum 4 year / bachelor's degree in a related field.
• Minimum 5 years related work experience including 2 years supervisory.
• 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.

Responsabilités

• 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.

Connaissances

Quality Management

GMP compliance

ISO 9001

CAPA

Root cause analysis

Formation

Bachelor's Degree in Related Field

Outils

Microsoft Office

Description du poste

RR Donnelley in California is seeking a Quality Assurance Manager to oversee the site Quality Management System and drive continuous improvement of quality performance.

You will partner with site leadership to ensure regulatory and customer requirements are met, coordinate ISO 9001:2008 and GMP practices, lead CAPA investigations and audits, and mentor the quality team to sustain robust metrics and a culture of quality.