Quality Assurance Compliance Specialist

Seeking an experienced QA Compliance Specialist to support quality assurance operations within a regulated cGMP manufacturing environment. This role will partner closely with manufacturing, engineering, and quality teams to ensure compliance with internal quality systems, FDA regulations, and GMP requirements while supporting batch record review, product release, and shop floor QA activities.

• Review and approve supplemental logs, charts, and documentation supporting cGMP operations
• Ensure batch records are accurate, complete, and compliant prior to product release
• Perform product release activities for finished goods, fills, and intermediates
• Review and approve incoming materials for release
• Provide real-time QA support to manufacturing operations, including line clearances
• Perform in-process checks to ensure adherence to procedures and specifications
• Monitor manufacturing activities for compliance with GMP and internal procedures
• Support operators and supervisors with GMP guidance and documentation practices
• Assist with quality investigations including nonconformance reporting and root cause analysis
• Issue, review, and reconcile batch records
• Support internal, customer, and regulatory audits
• Assist with maintenance and continuous improvement of the Quality Management System (QMS)
• Participate in cross-functional project teams

• Experience working in GMP/cGMP manufacturing environments
• Strong experience with batch record review and QA documentation review
• Knowledge of FDA regulations and ISO quality requirements
• Experience supporting QA compliance activities within regulated industries
• Strong attention to detail and organizational skills
• Excellent written and verbal communication skills
• Experience in medical device, biotech, or pharmaceutical manufacturing environments preferred
• Bachelor’s degree or equivalent industry experience preferred

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

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