Quality Assurance Specialist

Job Title: Quality Assurance Specialist
Location: Ridgefield, NJ
Duration: 12 Months

Job Summary:
The Quality Assurance Specialist is primarily responsible for performing AQL visual inspections of filled syringes and vials following successful qualifications. This role supports Manufacturing and Packaging Operations by ensuring that incoming materials and finished products meet established quality standards and regulatory requirements. The position requires sound judgment, attention to detail, and the ability to work independently within a cGMP-regulated environment.

Key Responsibilities:
• Primary responsibility is performing AQL visual inspection of filled syringes and vials following successful qualification.

Additional Responsibilities:
• Make sound, independent decisions regarding packaging inspections, rework operations, and final disposition of incoming materials in accordance with Thermo Fisher policies and procedures, with minimal supervision.
• Prioritize incoming inspections of primary, secondary packaging components and printed materials to align with Manufacturing and production needs.
• Act as a liaison with suppliers to resolve quality-related issues efficiently.
• Provide quality oversight and support to Packaging and Manufacturing Operations, including logbook and AQL inspection form review and real-time issue resolution.
• Participate in continuous improvement initiatives to streamline inspection processes and eliminate redundancies.
• Apply ANSI/ASQ Z1.4 sampling plans, including normal, reduced, and tightened inspection levels and switching rules.
• Ensure compliance with cGMP requirements related to inspection activities.
• Interpret component drawings and perform measurements using tools such as calipers and micrometers.
• Review and evaluate Certificates of Analysis (CoAs) for raw materials, chemicals, and packaging components.
• Collaborate with Purchasing and suppliers to resolve documentation discrepancies and shipping issues.
• Maintain accurate and compliant documentation in accordance with company and regulatory standards.
• Adhere to all Thermo Fisher safety policies and promote safe work practices.
• Support cross-functional teamwork and effective communication across departments.

Qualifications (Required)
• Knowledge of cGMP regulations as they relate to inspection and quality activities.
• Ability to read and interpret technical drawings and specifications.
• Experience using measurement tools such as calipers.
• Strong attention to detail, organizational skills, and documentation practices.
• Effective communication and teamwork skills.
• Ability to make independent decisions with minimal supervision.

Qualifications (Preferred)
• Working knowledge of AQL inspection processes and ANSI/ASQ Z1.4 sampling standards.
• Familiarity with normal, reduced, and tightened inspection levels and switching rules.
• Experience in pharmaceutical, biotechnology, or medical device manufacturing environments.
• Knowledge of sterile manufacturing or drug/medical device packaging operations.
• Prior experience evaluating Certificates of Analysis (CoAs).

Education & Experience:
• High school diploma or equivalent required.
• Associate’s degree in a scientific or technical field preferred.
• 2 years of experience in quality inspection, manufacturing, or a related GMP-regulated environment preferred.

Work Environment & Schedule
• Monday–Friday schedule with flexibility for early or late hours as needed.
• Occasional weekend support may be required based on business needs.
• Work performed in a manufacturing and/or controlled environment requiring adherence to gowning and safety procedures.