Quality Specialist III – RR Donnelley – Lemont, IL

Quality Specialist 3

Job Title: EHS / Quality Specialist 3

Reports to: Director of Operations or VP Manufacturing

Supervision: Indirect
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.

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.

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.

Apply via following link:

https://rrdonnelley.silkroad.com/epostings/index.cfm?fuseaction=app.jobinfo&id=23&jobid=202351&company_id=16098&version=1&source=ONLINE&JobOwner=992533&level=levelid2&levelid2=36338&startflag=3