Job Description

Kelly Science is seeking a Quality Assurance Production Associate for a growing company located in New Haven, CT.

Pay: $20-22/hour

Shift: 7:00am-3:30pm OR 8:30am-5:00pm

Employment Type: Contract to Hire

Summary:

The Quality Assurance/Production Associate holds a dual role, supporting both the Quality Assurance (QA) and Production teams to keep the site’s Quality Management System (QMS) and production processes running smoothly. In QA, you’ll manage company training records, review customer complaints, and assist with initiating or reviewing change requests. On the production side, you’ll inspect incoming materials, assemble kits, fulfill orders, service returned devices, and handle inventory management through NetSuite.

Job Duties include:

• Review and update SOPs, work instructions, and quality records to meet regulatory standards.
• Manage changes to procedures and quality management documents; support Change Control closure.
• Handle customer complaints and feedback.
• Maintain up-to-date employee training records for compliance.
• Assist with refurbishing devices, fulfilling orders, and assembling products.
• Perform quality checks on devices.
• Ensure all tasks follow ISO 13485, GMP, and FDA regulations, as well as company policies and safety requirements.
• Complete assigned training and support other quality and production tasks as needed.

Qualifications:

• Bachelor's degree in a scientific related field preferred
• Previous work experience with QMS documents/processes within a regulated environment (ISO 9001 or ISO 13485)
• Strong understanding of GMP and 21 CFR Part 820 strongly preferred.

Interested? Please apply today for immediate consideration!

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