QA Compliance Specialist

We are hiring on behalf of our client for a QA Compliance Specialist I to support Quality Assurance activities within a regulated manufacturing environment.

This role plays a key part in ensuring compliance with internal Quality Systems, cGMP requirements, FDA regulations, and ISO standards. The position includes documentation review, product release activities, and real-time, on-the-floor QA support to manufacturing operations.

Position Overview

The QA Compliance Specialist I is responsible for maintaining product quality and regulatory compliance through documentation review, in-process oversight, and support of quality systems and audit readiness.

This is a highly collaborative role working closely with Production, Engineering, and Quality teams to support both daily operations and continuous improvement initiatives.

Key Responsibilities

Documentation Review & Product Release

• Review and approve batch records for accuracy, completeness, and compliance prior to release
• Perform product release activities for finished goods, intermediates, and in-process materials
• Review and approve incoming materials for release
• Review supporting documentation, including logs, charts, and cGMP records

On-the-Floor QA Support

• Provide real-time QA support to manufacturing operations
• Perform line clearances and in-process quality checks
• Monitor production activities to ensure adherence to GMP and internal procedures
• Support operators and supervisors with GMP guidance and documentation best practices
• Conduct real-time documentation review during production

Quality Systems & Investigations

• Support deviation investigations, including nonconformance reporting and root cause analysis
• Issue, review, and reconcile batch records as needed
• Assist in maintaining and improving the Quality Management System (QMS)
• Participate in cross-functional initiatives to support quality and operational improvements

Audit Support & Compliance

• Support internal, customer, and regulatory audits
• Maintain working knowledge of applicable regulatory requirements
• Ensure ongoing inspection readiness

Required Qualifications

• Bachelor’s degree or equivalent combination of education and experience
• Experience in a medical device or regulated quality environment (internship experience considered)
• Working knowledge of cGMP, FDA regulations, and ISO standards (ISO 13485 preferred)
• Proficiency with Microsoft Office and quality/database systems
• Strong written and verbal communication skills