Quality Control Inspector

Our client is seek a Quality Control Inspector.

Position Summary

The Quality Control Inspector is responsible for inspecting materials, components, and finished products throughout various stages of production to ensure compliance with quality standards, regulatory requirements, and established procedures.

Work Schedule

• Full-time position.
• Standard shift start time is between 5:00 AM and 6:00 AM, depending on production schedules and business needs.
• Employees must be able to reliably report to work during this start-time window.
• Overtime and occasional schedule adjustments may be required.

Qualifications

• Understanding of global pharmaceutical product regulations with ISO 9001 and/or 13485:2003 and 21 CFR Parts 210 and 211 and/or Part 820.
• Demonstrated ability to perform GMP operations following detailed SOPs, good documentation practices.
• 1+ years’ experience with technical documentation in the areas of quality manufacturing that includes quality inspections and corrective actions in a pharmaceutical or medical device environment.
• Solid organizational and planning skills.
• Knowledge of ISO/GMP environments, SOPs, technical documentation, quality inspections, measurement tools, ERP systems, strong communication, organization, and attention to detail.

Essential Duties and Responsibilities

• Perform quality inspections and activities to ensure compliance with applicable regulatory and quality requirements.
• Conduct incoming, first article, in-process, and final product inspections.
• Initiate and document Nonconformance Reports (NCRs).
• Support investigations related to quality issues and nonconformances.
• Ensure inspections, testing activities, and documentation are completed accurately.
• Approve or reject raw materials based on quality standards.
• Prepare quality metrics and inspection reports.
• Review and release production documentation.
• Follow all safety requirements and wear required PPE.
• Participate in continuous improvement initiatives.
• Perform other duties as assigned.

Education and Experience

• High school diploma or equivalent required.

• Minimum 3 years of quality control inspection experience in a manufacturing environment.

• Experience in pharmaceutical, medical device, life sciences, or other regulated industries preferred.