Quality Specialist III – RR Donnelley – Lemont, IL
Quality Specialist 3
Job Title: EHS / Quality Specialist 3
Reports to: Director of Operations or VP Manufacturing
Position Summary / Description
Act as the site EHS & Quality Lead, oversee the implementation, maintenance and continual improvement of the site Environmental, Health & Safety, Quality Management System, and EHS / Quality Metrics performance. Works with site management and personnel to plan, develop, implement and continually improve site relevant EHS / QMS requirements, and to ensure sustainable compliance to customer, regulatory and RR Donnelley EHS / QMS requirements.
This role reports directly to the site manager and has a strong dotted-line report to the Platform EHS & Quality Lead within the business platform.
- Provides ongoing leadership and support for the maintenance and continual improvement of site Quality Management System (QMS) processes inclusive of food safety / contact & Medical Device / Pharma GMP’s as required.
- Provides ongoing leadership and support for the maintenance and continual improvement of site Environmental Health and Safety program & processes.
- Ensures that site QMS is in compliance with RRD QMS requirements including Quality Task Tracker and Quality Metrics reporting.
- When applicable, coordinates activities to maintain relevant Quality System requirements such as ISO 9001:2008, GMP (21 CFR Part 820) etc, including preparing for and scheduling of annual certification compliance audits.
- Informs site management on significant or potentially significant quality issues or on any issues for designated high risk accounts.
- Reviews all spoilage errors and any errors for designated high risk accounts and approves root cause analysis and corrective/preventive actions to ensure the risk of repeat is reduced or eliminated.
- Informs the Platform Quality Lead on significant or potentially significant quality issues
- Facilitates continual improvement through effective root cause analysis and corrective and preventive actions to reduce or eliminate errors.
- Responsible for the monitoring, measurement and trending of QMS processes including where applicable relevant GMP/HACCP 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.
- Interact with customers as requested and assist with quality related responses to RFP’s/RFI’s for the site.
- Where applicable review relevant GMP documents for compliance to company SOPs, quality systems, and regulatory requirements.
Job Knowledge & Skills
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.
- Effective verbal and written communication skills.
- 5-7 years of experience in a related position required.
- Solid Environmental Health and Safety knowledge preferred.
- Internal Auditor or Lead Auditor qualification or experience is preferred.
- Good leadership skills and ability to work effectively across various employee levels.
- Self-motivated individual with good problem-solving skills and analytical ability.
- Knowledge of and experience with ISO related quality management systems, is preferred.
- Working knowledge of GMP regulations and experience with regulatory compliance inspections.
- Working knowledge and experience with 21CFR210, 21CFR211, and Part 820.
- Working knowledge and experience with Food Safety auditing with third party inspectors.
- Working knowledge of HACCP/Food Safety Regulations.
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