Working Hours - 1pm to 9pm EST

Primary Purpose of the Position

The Quality Control Associate I will be responsible for performing in-process and final inspections of multiple products prior to shipment, ensuring that they meet customer specifications. This includes using various gauges, tools, and inspection techniques to accept or reject products, reporting findings to supervisors, and documenting issues according to inspection criteria.

Key Responsibilities

• Perform inspections of in-process and final products using designated gauges and tools to ensure product quality meets specified standards.
• Record inspection results accurately on designated forms, ensuring traceability of information such as process parameters, gauge calibration ID, lot/batch number, item/sku number, and date, following Good Documentation Practices (GDP).
• Procure inspection samples from in-process or finished products as outlined in inspection documentation, including handling cartons, re-taping, and replacing products on skids/pallets.
• Inspect labels, lot numbers, packaging, and configuration for compliance with specifications.
• Reject defective products, notify manufacturing supervisors, and write Non-Conformance Material Reports (NCMR).
• Coordinate with Operations to pull defective products off skids/pallets and ensure they are moved to rework or quarantine areas.
• Re-audit products after rework to ensure acceptability.
• Maintain daily logs for reference by inspectors on other shifts.
• Provide troubleshooting support to operators, supervisors, and technicians.
• Assist with inspection and testing of validation samples, raw materials, and incoming products when needed.
• Maintain a clean and safe work area, adhering to GMP, ISO standards, and company policies.
• Perform other related duties as assigned.

Working Conditions

• Exposure to industrial machinery, electrical components, and energy sources.
• Personal Protective Equipment (PPE) required (lab coats, gloves, ear protection, eye protection, hair/beard covers).
• Exposure to chemicals (cleaners, inks, solvents) and high-frequency noise.
• Physical activity includes frequently lifting up to 25 pounds and occasionally up to 65 pounds.

Minimum Qualifications

• High School Diploma or GED required.
• At least 1 year of experience in a manufacturing environment.

Preferred Qualifications

• Minimum 1 year of experience in quality inspections or a quality control role.
• Ability to work effectively in a team environment.
• Ability to read and understand standard operating procedures, work instructions, and forms.
• Strong math skills (e.g., basic addition and subtraction).
• Willingness to participate in ongoing on-the-job training regarding product, cGMP/Quality, equipment, processes, and performance.