QA Compliance Specialist

Status:
Accepting Candidates

Support QA and manufacturing operations by ensuring compliance with GMP, FDA, and ISO requirements through batch record review, product release, and on-the-floor quality support.

• Review and approve batch records, supplemental logs, and manufacturing documentation for GMP compliance.
• Perform product release activities for finished goods, intermediates, and fills.
• Provide real-time QA support on the manufacturing floor, including line clearances and in-process checks.
• Review and approve incoming materials for release into production.
• Support quality investigations including nonconformances and root cause analysis.
• Assist with audit readiness, documentation control, and continuous improvement of the Quality Management System.

• Experience in GMP-regulated manufacturing or medical device/pharmaceutical quality environments.
• Strong understanding of GMP, FDA, and ISO 13485 requirements.
• Hands‑on experience with batch record review and quality documentation.
• Strong attention to detail, communication, and organizational skills.
• Proficiency in Microsoft Office and quality/document control systems preferred.

Estimated hourly range: $30–$32/hr (W-2).

Final rate within this range will be based on skills, experience, and interview results.