The Quality Control Specialist is responsible for coordinating and executing a variety of quality assurance activities to ensure compliance with regulatory standards and internal requirements related to the mailing of sample collection devices directly to patients. This role plays a critical part in maintaining product quality and ensuring patient safety, privacy, and satisfaction.

Key Responsibilities:

• Develop and draft specifications and documentation for direct-to-patient mailings and their components.
• Manage document routing and approvals through the controlled document management system.
• Review and approve labeling for patient mailings to ensure accuracy and compliance.
• Conduct inspections of incoming materials and components in accordance with established quality procedures.
• Determine and document material disposition (e.g., accept, reject) based on product specifications.
• Perform material and product release activities, ensuring compliance with applicable quality standards.
• Verify patient information and component availability before initiating shipment, maintaining HIPAA compliance at all times.
• Perform in-process inspections of patient mailings to confirm adherence to specifications.
• Identify, reject, and document nonconforming materials according to internal protocols.
• Participate in continuous improvement initiatives and process validation efforts.
• Support other QA/QC functions as needed.
• Consistently apply knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Maintain a clean and organized work area; ensure proper use and care of office and quality-related equipment.

Qualifications:

• Bachelor's degree required (Science or Engineering preferred); 4–6 years of related experience in quality control or assurance.
• Prior experience in GMP-regulated environments such as medical device, pharmaceutical, or biotech industries strongly preferred.
• Solid understanding of quality management systems and regulatory requirements.
• Detail-oriented with strong organizational and time-management skills.
• Excellent written and verbal communication skills.
• Proficient in Microsoft Office Suite and document management systems.
• Ability to interpret and follow written procedures accurately.
• Comfortable working in a cross-functional team and independently.