Job Description
RRD is seeking a Manager, Quality Assurance 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
Education
Minimum: 4 Year / Bachelors Degree in Related Field
Preferred: **** Graduate Degree in Related Field
Years of Experience
Minimum 5+ years related work experience including a minimum of 2 years of supervisory experience.
Skills and Certifications
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
The national pay range for this role is $84,100 to $134,600/ 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 may also include participation in a bonus, commission or incentive program. 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.
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All employment offers are contingent upon the successful completion of both a pre-employment background and drug screen.
RRD is an Equal Opportunity Employer, including disability/veterans