Quality System Coordinator

Job description

Quality System Coordinator
Wickliffe, OH
$25-35/HR
Contract (Possibility of Extension)

Overview of the Quality System Coordinator Role
The Quality System Coordinator is responsible for the daily execution of activities related to the Quality Management System (QMS) for Pilot Plant manufacturing processes that adhere to ISO 9001 standards. This individual ensures that quality documentation, controlled files, CAPAs, deviations, corrective actions, calibration processes, audit support, and management review contributions are carried out with accuracy, consistency, and timeliness. The role requires collaboration with Pilot Plant leadership while receiving quality oversight; however, final decisions regarding QMS governance, certification strategies, and audits are retained by the Quality leadership.

Key Responsibilities of the Quality System Coordinator

• Facilitate the implementation, upkeep, and enhancement of the Pilot Plant quality system to comply with ISO 9001 standards and ensure readiness for certification.
• Accurately enter, maintain, and monitor CAPAs, deviations, nonconformances, out-of-trend/out-of-specification events, corrective actions, and related follow-up in ETQ or other recognized quality systems.
• Assist in managing document control for batch instructions, data logs, controlled procedures, quality records, and other relevant manufacturing documents; ensuring all records are complete and stored correctly within controlled systems.
• Handle the approval of batch instructions for production runs and ensure the appropriate separation of R&D documentation from production materials.
• Contribute to the Management of Change (MOC) documentation pertaining to any changes in processes, equipment, procedures, or quality systems that impact Pilot Plant operations.
• Collaborate with Maintenance, Engineering, and Quality teams to confirm the calibration status of quality-critical equipment, ensure proper completion of preventative maintenance, and report any overdue activities.
• Support various audits—internal, corporate, customer, and third-party—by preparing necessary records, organizing audit procedures, and ensuring timely responses to audit inquiries.
• Aid in the creation and delivery of QMS-related training for current, new, and transitioned Pilot Plant employees, highlighting the practical application of ISO 9001 requirements in their operational duties.
• Gather and systematize data for quality objectives, KPIs, management review contributions, follow-ups on internal audits, verification of corrective actions, and monitoring quality-system performance.
• Assist in risk and opportunity assessments, coordinate the collection of information for customer quality surveys, manage quality complaints, and oversee responses in conjunction with Quality leadership.
• Raise issues regarding quality concerns, overdue actions, documentation discrepancies, or potential QMS integrity risks to the Pilot Plant Manager and Senior Quality Manager as necessary.

Qualifications for the Quality System Coordinator

• A high school diploma or an equivalent qualification is required; a Bachelor’s degree from an accredited institution is preferred. Relevant experience in manufacturing, quality, technical operations, or related fields may be considered based on company requirements.
• Prior experience in a Pilot Plant, manufacturing, technical, operational, or quality-system capacity with a solid grasp of batch operations and production documentation.
• Proven ability to function within ISO 9001 compliance requirements and implement quality expectations effectively in a production setting that balances risk.
• Familiarity with batch instructions, controlled procedures, records management, document repositories, ETQ or similar electronic quality systems, and MOC documentation.
• Exceptional attention to detail, organizational skills, and the ability to manage multiple tasks until completion while escalating any delays or risks as needed.
• Skilled in facilitating collaborative sessions, collecting objective evidence, fostering group contributions, and effectively communicating with Operations, Quality, Engineering, Maintenance, and other relevant stakeholders.
• Basic knowledge of CAPA, deviations, nonconformances, corrective actions, root cause analysis, and methods for effectiveness verification.
• Experience in preparing records for audits and participating in internal, corporate, customer, or third-party audit processes in a chemical manufacturing framework.
• Awarded ISO 9001 knowledge, training in internal auditing, or leading auditor training is beneficial; while certification is preferred, it is not mandatory for the coordinator position given the oversight from Quality management.