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 IND2