Quality Assurance Specialist IV - Investigations

TITLE: Quality Assurance Specialist IV - Investigations

REPORTS TO: Quality Assurance Senior Manager - Operations

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 IV - Investigations role, leads and manages CGMP Quality Events across the site, including deviations, nonconformances, and investigations as applicable in accordance with Velocity Bioworks policies, procedures, and applicable CGMP requirements. This role ensures accurate, thorough, and timely investigation execution, including root cause analysis, impact and risk assessment, and the development, implementation, and effectiveness verification of associated CAPAs.

This role serves as a subject matter resource for investigation best practices and mentors assigned investigators as needed.

The position partners cross‑functionally with Manufacturing, QC, Material Management, Validation, IT, and other groups to drive corrective and preventive actions, remove roadblocks, identify trends and recurring issues, and implement improvements that strengthen product quality, compliance, and inspection readiness.

The successful candidate is detail‑oriented, highly organized, and able to prioritize effectively in a fast‑paced, dynamic environment. This role requires a high degree of independence, strong technical writing skills, sound judgment, and the ability to influence across functions to deliver high‑quality investigation outcomes on schedule at Velocity Bioworks.

• Bachelor’s degree in scientific or engineering discipline (or equivalent combination of education, training, and relevant experience) required.
• Minimum 5 years of experience in a regulated CGMP environment (biologics, cell therapy, pharmaceuticals, or medical device), including at least 4 years in QA or QC, and at least 1 to 2 years leading investigations and CAPA activities.
• Experience with batch record review and disposition activities preferred.
• Experience supporting mammalian and microbial manufacturing operations, including QC and supply chain and/or shipping activities preferred.

• Advanced knowledge of deviation and nonconformance management, including investigation authoring, review, approval, and timely closure.
• Advanced knowledge of CAPA lifecycle management, including development, implementation, effectiveness verification, and sustaining actions
• Advanced knowledge and demonstrated experience performing root cause investigations using structured methodologies and quality risk management principles.
• Strong working knowledge of CGMP requirements and quality systems supporting clinical stage manufacturing and QC laboratory operation
• Demonstrated ability to critically evaluate data, interpret results, and develop clear, technically sound conclusions supported by evidence and risk‑based rationale
• Excellent technical writing skills with the ability to produce clear, complete, inspection‑ready investigations, CAPAs, and management communications
• Ability to communicate investigation status, quality risk, and decisions to cross‑functional stakeholders and management with clarity and accuracy
• Proven ability to collaborate effectively across Manufacturing, QC, Supply Chain, Validation, and other functions to drive on‑time investigation and CAPA closure
• Proactively identifies and resolves investigation or CAPA roadblocks, escalates appropriately, and drives alignment to protect patient safety and product quality
• Action‑orie…