Quality Systems Analyst

Job Title

Pay Range: $120/hr - $125/hr

• Bachelor’s degree (scientific discipline preferred) and 4+ years of demonstrated quality experience in a GMP environment or the pharmaceutical/biopharmaceutical industry.
• Strong written and verbal skills.
• Ability to communicate across various cross-functional teams.
• Ability to work independently and drive pending actions to completion.
• Experience in GXP document review.
• Strong computer skills – Word, Excel, and other electronic Quality systems.

• Assist in Quality oversight for external GMP production and testing activities for clinical stage products and materials.
• Review master batch records, executed batch records, analytical testing protocols, methods, reports, testing records, stability documentation, and other quality documentation as needed.
• Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
• Perform review of Regulatory submissions and source data verification.
• Assist in establishing and maintaining internal procedures in compliance with FDA, ICH, EU, and other country-specific regulations.
• Other duties as assigned.
• Manage review and approval of analytical testing protocols, methods, and qualification/validation reports.
• Support review of regulatory filing activities as needed.
• Support SMEs in managing documents through the review, approval, and release workflow in the eQMS (e.g., Veeva Vault).
• Serve as a resource and coach for SMEs navigating quality processes and eQMS workflows.
• Identify and escalate quality issues or systemic trends to Quality Management.
• Support audit readiness by ensuring quality records are complete, accurate, and on time.
• Contribute to continuous improvement initiatives within the Quality Systems function.