Job Description

RR Donnelley is hiring a Quality Assurance Manager at their West Chester, OH Manufacturing location!

As Quality Assurance Manager, this role is responsible for overseeing the implementation, maintenance and continuous improvement of the site Quality Management System and Quality Metrics performance. The QA Manager 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 Site Leader, with a strong dotted-line report to the Platform Quality Leader within the business platform.

Responsibilities include:

• Provides ongoing leadership and support in maintaining and continually improving the site Quality Management System (QMS) and processes inclusive of food safety / contact & Medical Device / Pharma cGMP’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 Quality System requirements such as ISO 9001:2015, cGMP (21 CFR Part 820), etc., including preparing for, scheduling and leading annual certification compliance audits.
• Leads ongoing internal process verification audits throughout year.
• Evaluates the effectiveness of relevant site QMS processes (such as ISO 9001:2015, cGMP (21 CFR Part 820)) through internal audits and analysis of site Quality Metrics data to drive continuous improvement in the QMS.
• Ensures all QMS and cGMP documents are reviewed annually and modified as-needed for on-going compliance to company SOPs, the QMS, and regulatory requirements.
• 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.
• Collects and submits quality task tracker and quality metrics data for the site on a monthly basis, and reports site metrics and quality data to the Platform Quality Lead.
• Interacts with customers and responsible for quality related inquiries, responses to corrective action requests and facility audits as requested.
• Drives CAPA items to timely completion.
• Ensures compliance to customer requirements such as COC, FAI, AQL and that any deviations to specification are appropriately investigated and recorded.
• Ensures assigned programs are completed on schedule (calibration, safety, etc.)
• Provides leadership and direction to quality department employees.
• Participates in other activities as assigned.

Qualifications

• Bachelor of Science Degree with a minimum of 5 years related work experience including a minimum of 2 years of supervisory experience, or equivalent experience in a comparable role.

• Advanced training or experience in ISO and cGMPs required.

• Ability to understand and interpret federal regulations and company operating procedures as they apply to printing regulated product and quality issues.

• Must be able to prioritize and multi-task with minimal supervision.

• Strong attention to detail with excellent written and verbal communication skills.

• Knowledge of PC systems and Microsoft Office Suite (Word, Excel) required.

• Quality Assurance: 5 years

• CAPA: 5 years

• FDA Regulations and Procedures: 3 years

• ISO 9001:2015: 3 years

• Supervisory: 2 years

• cGMPs: 1 year

• Printing experience strongly preferred

Additional Information

The national pay range for this role starts at $74,600 /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.

All your information will be kept confidential according to EEO guidelines.

RRD is an Equal Opportunity Employer, including disability/veterans