Quality/EHS Specialist 3
Location:
Lemont , Illinois
Posted:
February 07, 2017
Reference:
205476

Position Summary / Description

Act as the site’s Quality & EH&S Lead, oversees the implementation, maintenance and continual improvement of the site’s 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.

Responsibilities

 

  • 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.

A little about us:
Join a company changing the fast-moving world of communications, where people like, link, pin, post and share. At RR Donnelley, we do it all.

Know someone who would be interested in this job? Share it with your network.