Overview

Quality Systems Specialist Jobs in California, United States at United Pharma

Title: Quality Systems Specialist

Company: United Pharma

Location: California, United States

Now Hiring Quality Systems Specialist

We are currently looking for an experienced Quality Systems Specialist to support a leading pharmaceutical/medical device company in California. This opportunity is ideal for professionals with strong expertise in GMP compliance, quality systems management, documentation control, and regulatory support within regulated environments.

🔹 Position: Quality Systems Specialist

🔹 Location: California (Onsite/Hybrid)

🔹 Duration: 12+ Months Contract

🔧 Key Responsibilities:

• Support and maintain Quality Management System (QMS) activities in compliance with GMP and FDA regulations

• Manage and support CAPA, deviations, change controls, non-conformance investigations, and audit activities

• Review, revise, and maintain SOPs, controlled documents, and quality records

• Collaborate with cross-functional teams including Manufacturing, Validation, Regulatory, and Quality Assurance

• Assist with internal/external audits and ensure timely closure of quality actions

• Support continuous improvement initiatives related to quality systems and compliance

• Ensure documentation accuracy, completeness, and regulatory readiness

✅ Required Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or related field preferred

• 3–6+ years of experience in Quality Systems within pharmaceutical, biotech, or medical device industries

• Strong knowledge of GMP, FDA, and regulatory compliance standards

• Hands-on experience with CAPA, deviations, audits, and document control systems

• Strong communication, analytical, and organizational skills

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