Quality Assurance Technician

Hound Diagnostics is a rapidly growing drug testing organization, developing next-generation laboratory testing solutions. We are seeking a detail-oriented Quality Assurance Technician responsible for ensuring all manufactured products meet established specifications, quality standards, regulatory requirements, and internal release criteria prior to inventory disposition or customer shipment. Activities include document preparation, document control, product and material inspection, quality record review, and administrative support of validation and qualification activities.

The position works closely with Manufacturing and Engineering teams to ensure documentation is accurate, complete, and compliant with applicable procedures and regulatory requirements.

This role is ideal for a detail-oriented professional who wants to play a critical role in maintaining product quality, customer satisfaction, regulatory compliance, and commercial readiness.

• Issuance of DHRs and labels for commercial product manufacturing.
• Review completed production documentation with focus on accuracy, completeness, format and adherence to procedural requirements.
• Ensure traceability of raw materials, subassemblies, and finished products.
• Release or reject production lots based on established specifications and quality requirements.

• Perform incoming, in-process, and final product inspections.
• Conduct visual, dimensional, functional, and performance inspections.

• Author and revise departmental documentation.
• Maintain and manage controlled documents, archives and retention activities within corporate Document Management System.
• Administer training assignments and maintain training records.
• Support product and process qualification documentation, execution, and reporting.

• Participate in investigations involving product defects, failures, complaints, and deviations.
• Support root cause analysis and corrective/preventive action (CAPA) efforts.
• Ensure all deviations, nonconformances, and discrepancies are properly documented.
• Assist in implementation and verification of corrective actions.

• Ensure compliance with:
• Good Manufacturing Practices (GMP)
• Good Documentation Practices (GDP)
• Company Quality Management System (QMS)
• Participate in regulatory inspections and customer audits.
• Drive continuous quality improvement initiatives.

• Bachelor's degree in Science, Quality, Engineering, or Life Sciences, or a related technical field required.

• 2–4 years of experience in a regulated manufacturing industry with quality control, manufacturing quality, or product release experience
• Preferred industries:
  Diagnostic products, medical devices, pharmaceuticals, or biotechnology.
• Experience working within a Quality Management System (QMS) environment preferred.
• Experience with document control, technical writing, or quality system documentation preferred.
• Exposure to validation and qualification activities (IQ/OQ/PQ) preferred.
  
  Experience with Electronic Document Management Systems (eDMS) preferred.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Teams.
• Competence in DHR Review, incoming materials and final assembly inspection, and nonconformance product management.

• Strong technical writing and documentation skills.
• Excellent organizational skills and attention to detail.
• Ability to manage multiple priorities and meet deadlines.
• Strong verbal and written communication skills.
• Ability to work independently and collaboratively in a team environment.
• Strong analytical and problem-solving abilities.
• Working knowledge of regulated manufacturing environments and quality system requirements.
• Commitment to continuous improvement and compliance.

• Self-motivated and eager to learn.
• Comfortable working in a fast-paced and evolving environment.
• Collaborative team player with a positive attitude.
• Demonstrates initiative and ownership of assigned responsibilities.
• Open to feedback and committed to professional development.

• Days and hours of work may be variable depending on business need.
• Due to the “start-up” nature of the company, occasional evening and weekend work may be required as job responsibilities demand.

• Indoor position that requires sitting at computer for an extended period.
• Exposure to moderate to loud noise and light as typical in a lab or manufacturing environment.
• Ability to stand for extended periods of time and lift 50lbs unassisted.
• Work within clean room and dry room environments as required for product and manufacturing support.

• Join a confidential, high-impact drug testing organization
• Play a key role in building manufacturing and validation processes from the ground up
• Work in a collaborative, fast-paced, and technically challenging environment
• Competitive compensation and benefits

Salary range: $75,000 – $85,000/year depending on experience

Due to the…