QA Specialist

Cagents Inc.

Job Overview

Location

Sydney

Job Type

Full-time

Full Job Description

📋 Description

• QA Specialist role focused on commissioning, qualification, and validation in FDA-regulated industries such as pharmaceuticals, medical devices, and biotechnology, ensuring product quality and regulatory compliance.
• Day-to-day responsibilities include supporting validation projects from initiation to completion, testing equipment and processes, developing validation protocols, conducting risk assessments, ensuring cGMP compliance, and collaborating with cross-functional teams to maintain validation integrity.
• CAI is a 100% employee-owned company with nearly 700 global employees, specializing in commissioning, qualification, validation, and consulting services for mission-critical industries, with a culture rooted in integrity, teamwork, and continuous improvement.
• The role offers opportunities to work with subject matter experts on cutting-edge advanced medicine projects, gain hands-on certifications, contribute to lifesaving therapies like COVID-19 vaccines, and grow professionally within a collaborative, values-driven environment.

🎯 Requirements

• Bachelor’s degree in engineering, life sciences, or quality assurance (advanced degrees or certifications advantageous)
• Minimum 2 years of experience in validation, quality assurance, or related field in pharmaceutical, medical device, or biotechnology industries
• Strong understanding of FDA, EMA, ISO, TGA, and cGMP regulations
• Proficiency in validation management software and electronic documentation systems
• Excellent analytical skills, attention to detail, and project management abilities

🏖️ Benefits

• Employee ownership model where individual success contributes to team and company success
• Access to hands-on certifications and professional training investments
• Collaboration with recognized subject matter experts in advanced medicine
• Opportunity to work on impactful projects including lifesaving therapies and vaccines
• Culture emphasizing integrity, respect, teamwork, and continuous improvement

Skills & Technologies

Onsite

Degree Required

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Cagents Inc.

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About Cagents Inc.

Cagents Inc. provides a cloud-based platform that uses AI-driven automation to help businesses discover, qualify, and engage sales prospects. The software aggregates public data, scores leads, and triggers multi-channel outreach campaigns, integrating with CRM and email systems to streamline pipeline generation for B2B companies.

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