CI Specialist 3

RR Donnelley • Durham, NC

5d

About The Position

The CI Specialist 3 leads implementation, maintenance, and continual improvement of the site Quality Management System (QMS) and its performance. The role leads high-impact projects to optimize cost, quality, and operational performance, and serves as the primary site lead for continuous improvement. It influences leadership and partners to embed sustainable best practices, mentors staff in advanced methodologies and change management, and drives operational excellence at the site.

The position also provides expertise in environmental, health, and safety (EHS) initiatives and supports proactive programs designed to reduce injuries. It ensures adherence to company documentation and record-retention standards and helps maintain effective quality training resources.

Requirements

• Bachelor’s degree in a discipline related to the functional work.
• At least 5 years of relevant experience.
• Ability to apply broad work experience and knowledge to analyze complex problems and identify critical elements, variables, and alternatives to develop solutions.
• Ability to organize and prioritize existing resources and incorporate new information to implement effective solutions.
• Excellent business acumen and collaborative skills when resolving problems.
• Excellent communication skills, including the ability to communicate clearly and understand a message’s impact on the organization or customer.
• Practical understanding and application of computer systems, including Microsoft Windows and/or MAC environments, and the ability to use relevant technical tools and applications efficiently and accurately.
• Ability to apply expertise across relevant tools and applications and mentor junior team members in their use.
• Ability to maintain organizational integrity and a strong grasp of document-control standards.
• Strong leadership and communication skills, with the ability to work effectively across employee levels.
• Demonstrated leadership, facilitation, coaching, and organization skills.
• Internal Auditor or Lead Auditor qualification or experience.
• Demonstrated knowledge of ISO-related quality management systems.

Nice To Haves

• Demonstrated knowledge of and experience with cGMP and/or SOC2+ requirements.

Responsibilities

• Provide leadership for the QMS and ensure compliance with ISO and corporate quality standards.
• Provide root cause analysis and corrective/preventive action plan support to site leadership.
• Review CAPAs, spoilage incidents, and other errors for designated high-risk accounts; review and approve site leadership’s root cause analyses and corrective/preventive actions to reduce or eliminate repeat risk.
• Oversee internal audits and QMS performance metrics, and present findings to site leadership through regular Management Reviews.
• Develop and deploy advanced process-improvement methodologies to optimize cost, quality, and efficiency.
• Lead improvement projects, including EHS program development and sustainability for assigned programs.
• Monitor quality-related training requirements, including maintaining an effective level of trained quality resources.
• Ensure conformance with company standards for documentation and record retention.
• Assist in identifying, developing, and implementing proactive programs designed to reduce injuries.
• Provide expertise in EHS initiatives, including focus groups, safety programs, and change management.
• Mentor and guide staff in advanced methodologies and change management.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior