What are the responsibilities and job description for the Quality Assurance position at R.R. Donnelley?
Company Description
This full time job responsibility will be to act as the site Quality Manager, 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 Site Leader, with a strong dotted-line report to the Platform Quality Leader within the business platform.
Job Description
Work is typically performed under no supervision, with only guidance about overall goals and objectives. Usually receives minimal guidance about how to complete work objectives. Must be able to define work based on evaluation of short term and long term goals of the department. Able to independently evaluate processes, identify areas of improvement, and incorporate in to overall work objectives.
- 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
The duties and responsibilities described above are the essential functions of the job. The qualifications below are representative of the knowledge, skills, and / or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Additional job requirements may be listed on the staffing requisition.
Additional Information
RRD is an Equal Opportunity Employer, including disability / veterans
