ISO​/QA Coordinator

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Technical Ohio, Columbus, OH, US

7 days ago Requisition

Salary Range: $65,000.00 To $85,000.00 Annually

This position is responsible for maintaining all quality-related activities as it pertains to CRC’s customers and ISO compliance. This position is based in our Columbus, Ohio Plant. This position will require 5% to 8% travel to our Detroit, Michigan facility and for supplier visits.

• Quality Management System (QMS) Oversight: Maintain, update and continuously improve the QMS to ensure compliance with ISO:9001 standard, customer requirements and strategic business objectives.
• ISO Compliance Management: Coordinate activities related to ISO 9001 certification, surveillance audits, and recertification cycles.
• Internal Audits: Plan, schedule, and conduct internal audits, train and maintain an internal auditor team, track findings, verify corrective actions, and prepare audit reports. Conduct calibration and retain audits in QC department to ensure compliance with all SOPs.
• Document Control: Manage all controlled documents and ensure proper revision control and accessibility.
• Corrective and Preventive Actions: Lead CAPA investigations using structured problem‑solving tools (8D, 5-Whys) including working cross-departmentally to determine root cause, issue reports within the appropriate timeframe, and verify effectiveness of all corrective and preventative actions.
• Training Coordination: Maintain training records, support new-hire onboarding, and ensure all relevant associates are trained on appropriate quality tests, including annual refresher training.
• Nonconformance Management: Log, investigate, and close nonconformances; collaborate with operations, QC, and R&D to prevent recurrence.
• Supplier Quality Support: Assist with supplier evaluations, audits, and performance monitoring.
• Data Analysis and Reporting: Analyze data from all quality metrics and key performance indicators (KPIs). Report trends, deficiencies or problems to upper management in management review meetings or report to appropriate personnel.
• Continuous Improvement: Identify opportunities to streamline processes, reduce waste, and improve quality performance. Conduct quarterly R&R studies to identify issues and improve the quality test methods. Review all Management of Change (MOC) requests to ensure all quality risks are identified and determine opportunities to lower all quality risks. Observe manufacturing to enhance job knowledge.
• Customer Support: Support customer audits, respond to quality questionnaires, complete recertification testing promptly, serve as subject‑matter‑expert on certificates of analysis (COA) and support sales with all quality‑related questions.
• Product Support: Attend all pre- and post‑production meetings to ensure ISO compliance and to act as a liaison between QC and production.
• QC Support: Provide seamless and consistent support to our daily production, serve as a technical expert on test methods and instrumentation. Ability to support any gaps in QC lab coverage.
• Quality Culture: Continuously promote quality culture by publishing quality newsletter, engaging with all departments across all shifts and encouraging ISO compliance.
• Other: Participate in Process Safety Management (PSM) compliance activities and support the Environmental, Health, Safety and Quality management software.

• Bachelor's Degree in Chemistry, Quality Assurance, Business Administration, Engineering, Industrial Technology or a related field is required.

• 3 to 5 years of chemical laboratory experience is required.
• Two to five years of experience in quality assurance, document control, auditing, or quality systems administration preferred.
• Experience in a manufacturing environment required.
• Chemical manufacturing experience preferred.
• Experience working with ISO 9001 Quality Management Systems required.

• This position will be required to obtain the "ISO Lead Auditor Training" certification within the…