CI Specialist 3

RR Donnelley•Durham, NC

6d•$73,500 - $116,000

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, influencing leaders and partners to embed sustainable best practices. The specialist mentors and guides staff in advanced methodologies and change management and drives operational excellence within the site. The role also provides leadership for QMS compliance with ISO and corporate quality standards; supports site leadership with root cause analysis and corrective and preventive action plans; oversees internal audits and QMS performance metrics; and presents findings during regular Management Reviews. It develops and deploys process improvement methodologies, leads improvement projects including EHS program development and sustainability for assigned programs, monitors quality training requirements, maintains document and record-retention conformance, and supports proactive injury-reduction and other EHS initiatives.

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, identify critical elements, variables, and alternatives, and develop solutions.
Ability to organize and prioritize resources and incorporate new information to implement effective solutions.
Excellent business acumen and collaborative skills in resolving problems.
Excellent communication skills, including the ability to communicate clearly in language others can understand and understand the impact of messages on the organization or customer.
Understanding and practical application of computer systems, including Microsoft Windows and/or MAC environments, and ability to use relevant technical tools and applications effectively.
Ability to mentor junior team members in the use of relevant tools and applications.
Ability to maintain organizational integrity and strong understanding of document control standards.
Strong leadership and communication skills and ability to work effectively across all 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

Lead the implementation, maintenance, and continual improvement of the site QMS and its performance.
Ensure QMS 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 root cause analysis efforts and corrective/preventive actions to reduce or eliminate repeat risk.
Oversee internal audits and QMS performance metrics, presenting 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.