Quality Control Clerk

Description

Provides essential support for routine quality assurance functions to ensure compliance with regulatory requirements and maintain production flow. Responsible for executing established quality procedures including sample collection, documentation review, incoming inspections, and quality record maintenance to support the Quality Assurance team's strategic initiatives.

• Perform routine sample collection according to established sampling plans
• Execute sampling procedures consistently across production areas
• Maintain proper chain of custody for all collected samples
• Document sampling activities in compliance with regulatory requirements
• Review Device History Records (DHRs), Sterilization History Records (SHRs), and Lot History Records (LHRs) for accuracy and completeness
• Process quality documentation in compliance with regulatory requirements
• Ensure all records are complete, accurate, and properly documented
• Support timely processing to meet production schedules
• Conduct incoming inspections of materials and components according to established procedures
• Verify incoming materials meet specification requirements
• Document inspection results and maintain inspection records
• Process material acceptance/rejection decisions in ERP system
• Execute ERP/Shopfloor transactions related to quality processes
• Update quality system records and maintain data integrity
• Process quality-related transactions to support production flow
• Generate routine quality reports as assigned
• Maintain quality records and documentation systems
• Ensure proper filing and storage of quality documents
• Support document control activities as needed
• Assist with quality system organization and maintenance
• Support routine quality assurance activities across production areas
• Assist with quality clearance processes to minimize production delays
• Coordinate with production teams on quality-related matters
• Provide backup support for other quality assurance processes as needed

• 1-2 years of experience in manufacturing quality assurance
• Previous experience in a regulated manufacturing environment preferred

• Knowledge of quality documentation systems and regulatory requirements
• Familiarity with ERP systems and quality modules
• Basic understanding of statistical sampling techniques
• Understanding of manufacturing quality processes

• Strong attention to detail and record-keeping abilities
• Ability to follow established procedures consistently
• Effective written and verbal communication skills
• Proficient in Microsoft Office applications
• Ability to work independently with minimal supervision

• Working conditions include both office environment and manufacturing floor
• Must be able to sit, stand, and walk throughout most of a shift
• Occasional lifting of materials up to 25 pounds
• Must be detail-oriented and able to concentrate on repetitive tasks
• Ability to work in a fast-paced manufacturing environment

• Maintain documentation processing time targets (1 day average)
• Complete incoming inspections within 12-hour target timeframe
• Achieve 100% compliance with sampling plan execution
• Support reduction in quality-related production delays

This position is essential to maintaining quality standards while allowing senior QA personnel to focus on strategic compliance initiatives and complex quality issues. The Quality Assurance Clerk will receive comprehensive training on company-specific procedures and quality systems.