Description
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