RA QA SPECIALIST

Experience Required: Minimum 3 Years
Education: Bachelor’s Degree Preferred

We are seeking a detail-oriented and experienced Quality Assurance Specialist to support quality operations and compliance initiatives in a regulated environment. This individual contributor role requires sound professional judgment, the ability to work independently with minimal supervision, and a strong understanding of quality systems, regulatory compliance, and process improvement.

The ideal candidate will have hands-on experience implementing quality standards, supporting audits and inspections, and ensuring compliance throughout all stages of operational and production processes.

This position is an on-site office position. Must live in the local area.

Key Responsibilities

• Implement and maintain quality standards across all stages of the process
• Ensure compliance with internal procedures, regulatory requirements, and quality systems
• Assess potential quality and compliance risks and provide recommendations for mitigation
• Take ownership of quality control activities related to:
• Service Processes
• Testing and operations
• Production processes
• Finished products and services
• Facilitate internal audits and regulatory inspections
• Coordinate and support quality training initiatives
• Apply professional expertise and independent judgment to resolve quality-related issues
• Collaborate cross-functionally to drive continuous improvement and compliance excellence

Qualifications

• Bachelor’s degree preferred or equivalent in experience
• Minimum of 3 years of relevant quality assurance or quality control experience
• Strong understanding of quality systems, compliance standards, and regulated environments
• Experience supporting audits and regulatory inspections
• Ability to work independently with minimal supervision
• Strong analytical, organizational, and communication skills
• Practical knowledge gained through hands-on industry experience preferred

Preferred Skills

• Experience in medical device, pharmaceutical, biotech, or healthcare environments
• Familiarity with GMP, GLP, GCP, FDA, or ISO standards
• Strong problem-solving and risk assessment capabilities