Quality Assurance

Job Summary:
We are seeking a detail-oriented Quality Assurance Auditor – Assembly to support production operations in a fast-paced manufacturing environment. This role is responsible for inspecting incoming materials, auditing work-in-process, and verifying finished goods to ensure compliance with quality standards, customer specifications, and regulatory requirements.

Key Responsibilities:

• Inspect incoming materials to ensure conformance with specifications and approve for production use
• Audit assembly lines during production to verify compliance with work orders and customer requirements
• Perform quality checks on finished goods to ensure accuracy and defect-free output
• Ensure compliance with Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), and quality standards
• Review, approve, and release production documentation to support timely customer shipments
• Identify and communicate documentation or process issues to operations teams
• Accurately record and maintain quality data for internal analysis and reporting
• Communicate effectively with internal teams, including operations and project management, as needed
• Participate in internal audits, customer audits, and regulatory inspections
• Assist with or conduct cGMP and quality-related training as needed
• Maintain a clean, safe, and organized work environment
• Support continuous improvement initiatives and perform additional duties as assigned

Qualifications:

• High school diploma or GED required
• 2+ years of experience in a quality assurance or quality control role preferred
• Strong understanding of cGMP, SOPs, and quality systems (ISO experience is a plus)
• Proficiency in Microsoft Office (Excel, Word, Outlook)
• Ability to read and interpret technical documents, procedures, and safety guidelines
• Strong attention to detail, accuracy, and documentation skills
• Effective communication skills, both written and verbal

Work Environment & Requirements:

• Ability to work in a fast-paced production/assembly environment
• Strong organizational and problem-solving skills
• Commitment to safety, quality, and continuous improvement
• Overtime may be required based on production needs

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