Job Description

Job Description

Job Overview

The Quality Assurance Coordinator is responsible for overseeing quality control and quality assurance processes to ensure all manufactured products meet established quality, safety, and regulatory requirements. This role works closely with laboratory and operations teams to support compliance with FDA regulations , cGMP , and ISO standards , while driving continuous improvement across quality systems. The Coordinator is responsible for SOP implementation, quality documentation, laboratory and testing oversight, and regulatory readiness, ensuring consistent, accurate, and compliant manufacturing operations.

Key Responsibilities

• Own, author, review, and maintain Standard Operating Procedures (SOPs) and quality documentation
• Enforce SOP compliance across production and operations
• Support and maintain the Quality Management System (QMS)
• Perform and oversee basic chemical handling and quality control testing
• Lead and support internal audits and preparation for external audits (FDA, ISO, customer)
• Ensure ongoing compliance with FDA regulations and ISO standards (ISO 9001 or similar)
• Coordinate corrective and preventive actions (CAPA) and root-cause investigations
• Train employees on SOPs, quality standards, and compliance requirements
• Act as a primary point of contact for quality-related issues and continuous improvement initiatives

Qualifications

• 3+ years of experience in Quality Assurance within a regulated manufacturing environment
• Strong experience with FDA-regulated operations
• Working knowledge of ISO standards (ISO 9001 or similar)
• Hands-on experience with SOP authoring, enforcement, and documentation control
• Experience with basic chemical handling and quality control testing
• Ability to work independently and proactively in an on-site manufacturing setting
• Strong written and verbal communication skills

Preferred Qualifications

• Experience in chemical manufacturing or related industries
• Bilingual in Spanish (asset)
• Experience leading or supporting regulatory and customer audits
• CAPA, deviation investigation, and root-cause analysis experience
• Quality certifications (ASQ, ISO Auditor, Lean, Six Sigma)

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