Quality Assurance Specialist IV - Investigations
hace 13 días
San Antonio
Job DescriptionDescription: TITLE: Quality Assurance Specialist IV - Investigations REPORTS TO: Quality Assurance Senior Manager - Operations LOCATION: San Antonio, Texas (Onsite) 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. Position Summary 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 . Requirements: Education & Experience • 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. Knowledge & Skills • 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-oriented and solutions-minded with strong planning, organization, and analytical thinking skills, • Demonstrated ability to influence without authority, manage conflict constructively, and coach or mentor other investigators and new hires, • Works independently with minimal oversight, exercises sound judgment within established procedures, and escalates issues based on risk and complexity, • Knowledge of aseptic manufacturing processes and contamination control concepts, • Strong working knowledge of applicable GxP regulations and guidances, including FDA CGMP, EMA, and ICH, • Working knowledge of quality risk management principles and application to impact assessments, interim controls, and CAPA strategies, • Strong technical writing and documentation skills, including the ability to author and critically review complex investigations and CAPAs, • Strong verbal communication skills, including the ability to present complex quality issues to management and cross-functional stakeholders with a clear rationale, • Demonstrated ability to prioritize and manage multiple deliverables, meet closure timelines, and escalate based on risk and business impact, • Proficiency with Microsoft Office and electronic quality management systems, including deviation and CAPA workflows, metrics, and reporting tools, • Ability to read, interpret, and analyze complex documents, data packages, and technical reports to support investigation conclusions Physical Requirements & Working Environment • Work is performed on-site in an environmentally controlled CGMP-regulated biologics facility. The setting includes a combination of office, laboratory, and manufacturing environments with moderate noise levels., • Regularly required to sit, stand, and walk for extended periods. Must have the manual dexterity to use computer systems and the ability to occasionally lift or move up to 20 pounds., • Specific vision abilities required include close vision, color vision, and the ability to adjust focus for document and sample review., • Flexibility in working hours is required to align with manufacturing schedules. This may include occasional early mornings, late evenings, and weekend support as needed. Notice to Third Party Agencies: Velocity Bioworks does not accept unsolicited resumes from recruiters or employment agencies. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement and approved engagement request with Velocity Bioworks, Velocity Bioworks reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. Velocity Bioworks is proud to be an EEO/AAP Employer. Velocity Bioworks encourages protected veterans, individuals with disabilities, and applicants from all backgrounds to apply. Velocity Bioworks ensures nondiscrimination in all programs and activities in accordance with Title VI of the Civil Rights Act.
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