Work Location: Bergen County, New Jersey

Summary:

Seeking a Quality Assurance Associate for a contract-to-hire opportunity. This role focuses on batch record review, product release, and maintenance of quality systems in compliance with regulatory standards. The position supports increased production demands and requires a detail-oriented individual with a strong understanding of quality assurance processes.

Responsibilities:

• Review and release batch records for receiving, in-process, and finished products, ensuring compliance with regulatory standards.
• Maintain and update quality systems documentation in accordance with established procedures and industry regulations.
• Identify, document, and address issues related to product, process, or quality systems, recommending solutions as needed.
• Oversee the release or quarantine of materials based on inspection and test results, ensuring proper documentation.
• Support verification activities and ensure all processes follow standard operating procedures and quality guidelines.
• Qualify personnel for specific quality assurance tasks and provide necessary training or guidance.
• Initiate corrective or preventive actions to address nonconformities in products, processes, or the quality management system.
• Assist with special projects and perform additional duties as assigned to support quality and operational objectives.

Qualifications:

• Bachelor's degree or equivalent work experience in biological sciences, engineering, or a related field.
• Experience with batch record review and release documentation processes.
• Familiarity with packaging and labeling requirements for medical devices.
• Knowledge of cGMP, Good Documentation Practices, and quality systems.
• Ability to follow written and oral instructions with minimal supervision.
• Strong verbal and written communication skills, including report writing.
• Experience in a medical device or science-related field is a plus.

Published Category: Quality & Validation