Quality Assurance Manager - Healthcare jobs in Elyria, OH

Company Description

RRD is a leading global provider of marketing, packaging, print, and supply chain solutions that elevate engagement across the complete customer journey. The company offers the industry’s most trusted portfolio of creative execution and world-wide business process consulting, with services designed to lower environmental impact. With 22,000 clients, including 93% of the Fortune 100, and 32,000 employees across 28 countries, RRD brings the expertise, execution, and scale designed to transform customer touchpoints into meaningful moments of impact.

Job Description

The pharmaceuticals label site Quality Manager, is responsible for overseeing the implementation, maintenance and continuous improvement of the site Quality Management System and Quality Metrics performance. Works 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. This role reports directly to the VP of Operations, with a strong dotted-line report to the Platform Quality Lead within the business platform.

• 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.

Qualifications

• 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. Required experience:
• Job Type: Full-time
• Quality Assurance: 5 years
• FDA Regulations and Procedures: 3 years
• Supervisory: 3 years
• CAPA: 3 years
• cGMPs: 1 year

Additional Information

The national pay range for this role is $74,000 to $132,000 / year. The pay range may be slightly lower or higher based on the geographic location of the hired employee. The actual pay offered may vary based upon, but not limited to: education, skills, experience, proficiency, performance, shift and location. In addition to base salary, depending on the role, the total compensation package. RRD offers benefits including medical, dental, and vision coverage, paid time off, disability insurance, 401(k) with match, life insurance and other voluntary supplemental insurance coverages, plus tuition assistance, maternity leave, adoption assistance, and employer/partner discounts.

RRD is an Equal Opportunity Employer, including disability/veterans