Quality Assurance Specialist III - Operations

Quality Assurance Specialist III - Operations

Reports to:

Quality Assurance Senior Manager - Operations The Company

Velocity Bioworks is a U.S.

-based biopharma CDMO headquartered in San Antonio, Texas supporting funded programs as they move from development into manufacturing for clinical trials. We collaborate with sponsors who are past exploration and are ready to apply discipline, structure, and technical rigor to development, analytics, and manufacturing.

Velocity is built to accelerate speed to clinic through aligned execution. Our work focuses on translating defined program goals into scalable manufacturing processes and robust analytical strategies. These activities are designed to support near‑term clinical timelines while meeting quality requirements. We operate where quality and execution directly influence clinical and business progress.

The Quality Assurance Specialist III - Operations provides on‑site Quality Assurance support for GMP manufacturing operations and Material Management activities. Responsibilities include QA oversight during batch execution, review of executed batch records, logbooks, and labels, and oversight of GMP documentation to ensure adherence to internal procedures and CGMP requirements. This role partners with Manufacturing, Supply Chain, and other cross‑functional teams to identify and elevate quality issues, support deviation initiation and documentation, and maintain inspection‑ready practices across operations and materials workflows.

The position operates under moderate oversight and is expected to apply sound judgment, strong documentation practices, and a consistent compliance mindset in a fast‑paced clinical manufacturing environment at Velocity Bioworks.

• Provide on‑site Quality Assurance support to GMP manufacturing operations to ensure compliance with internal procedures and CGMP requirements.
• Provide QA oversight and guidance during GMP manufacturing activities to ensure compliance and timely escalation of issues based on risk.
• Review executed batch records and supporting documentation for completeness, accuracy, and adherence to procedures, and expedite discrepancies for resolution.
• Review and verify labels, label reconciliation, and labeling records to support accurate identification, traceability, and product disposition.
• Support line clearance activities, ensuring documentation and status controls are complete prior to start‑up and at closeout as applicable.
• Review logbooks and CGMP documentation associated with manufacturing activities to confirm entries are accurate, complete, and attributable.
• Provide QA oversight of Material Management activities, including receipt documentation review, labeling and status control, storage and segregation compliance, material movement controls, and issuance transactions to support traceability and compliance.
• Support review of material lifecycle documentation for completeness, including CoAs and supporting supplier documentation, and highlight gaps per procedure.
• Support equipment and validation program compliance by reviewing equipment qualification documentation as assigned, including protocols and reports, and reviewing calibration and preventive maintenance records for completeness, accuracy, and adherence to established requirements, escalating discrepancies as needed.
• Initiate quality events as needed and support documentation through timely information gathering, event triage support, and escalation to appropriate Quality leadership.
• Support quality system workflows linked to operations, including change controls, CAPA support activities, and SCAR support activities, with ownership level based on complexity and assignment.
• Participate in walkthroughs and routine compliance checks of manufacturing and materials areas, documenting observations and partnering with Operations and Supply Chain on corrective actions.
• Support inspection readiness activities, including documentation organization, records retrieval, and backroom support during internal and external audits.
• Contribute to SOP updates by providing input, reviewing revisions, and assisting with implementation activities as…