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Hunter International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, and gender expression), national origin, age, disability, genetic information, veteran status, or any other status protected by applicable federal, state, or local law. We comply with all applicable equal employment opportunity and affirmative action regulations.
Quality System Coordinator
Wickliffe, OH
Contract (Potential to extend)
Quality System Coordinator Overview
The Quality System Coordinator supports day-to-day execution of Quality Management System (QMS) activities for ISO 9001-aligned Pilot Plant manufacturing processes. The role helps ensure quality records, controlled documents, CAPAs, deviations, corrective actions, calibration interfaces, audit support, and management review inputs are completed accurately, consistently, and on time. This position is an execution and coordination role that works under the direction of Pilot Plant leadership with dotted-line Quality oversight; final QMS governance, certification strategy, final disposition, and audit decisions remain with Quality leadership.
Quality System Coordinator Responsibilities
- Support implementation, maintenance, and continuous improvement of the Pilot Plant quality system to meet ISO 9001 requirements and sustain certification readiness.
- Enter, maintain, and track CAPAs, deviations, nonconformances, out-of-trend / out-of-specification events, corrective actions, and related follow-up activities in ETQ or other approved quality systems.
- Support document control activities for batch instructions, data logs, controlled procedures, quality records, and other manufacturing documentation; ensure records are complete, accurate, and retained in controlled systems.
- Maintain approved batch instructions for production runs and support the required segregation of R&D documentation from production documentation.
- Support Management of Change (MOC) documentation associated with process, equipment, procedural, or quality-system changes impacting Pilot Plant operations.
- Coordinate with Maintenance, Engineering, and Quality to verify calibration status of quality-critical equipment, confirm PM completion status, and escalate overdue or missed activities.
- Assist with internal, corporate, customer, and third-party audits by preparing requested records, supporting audit logistics, and coordinating timely responses to audit requests.
- Support development and delivery of QMS-related training for current, new, and transferred Pilot Plant employees, including practical application of ISO 9001 requirements in operations.
- Collect and organize data for quality objectives, KPIs, management review inputs, internal audit follow-up, corrective action verification, and quality-system performance monitoring.
- Support risk and opportunity evaluations, customer quality surveys, quality complaints, and quality requests by coordinating information, records, and responses with Quality leadership.
- Escalate quality concerns, overdue actions, documentation gaps, or potential QMS integrity issues to the Pilot Plant Manager and Senior Quality Manager as appropriate.
- High school diploma or equivalent required; Bachelor's degree from an accredited university preferred; equivalent experience in manufacturing, quality, technical operations, or related fields may be considered based on business need.
- Current or prior Pilot Plant, manufacturing, technical, operations, or quality-system experience with strong understanding of batch operations and manufacturing documentation.
- Demonstrated ability to work within ISO 9001-aligned quality requirements and apply quality expectations in a practical, risk-balanced production environment.
- Experience with batch instructions, controlled procedures, records management, document repositories, ETQ or comparable electronic quality systems, and/or MOC documentation.
- Strong attention to detail, organization, follow-through, and ability to track multiple action items to closure while escalating delays or risks when needed.
- Ability to support collaborative working sessions, collect objective evidence, facilitate group input, and communicate clearly with Operations, Quality, Engineering, Maintenance, and other stakeholders.
- Working knowledge of CAPA, deviation, nonconformance, corrective action, root cause analysis, and effectiveness verification principles.
- Comfortable preparing audit-ready records and supporting internal, corporate, customer, or third-party audit activities in a chemical manufacturing environment.
- ISO 9001 awareness, internal auditor training, or lead auditor training preferred; formal lead auditor certification is considered a plus but is not required for the coordinator role when Quality oversight is maintained.
Hunter International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, and gender expression), national origin, age, disability, genetic information, veteran status, or any other status protected by applicable federal, state, or local law. We comply with all applicable equal employment opportunity and affirmative action regulations.
