Quality Management Systems Specialist III

Description Quality Management Systems Specialist III Reports To: Supervisor, Quality Management Systems Location: San Antonio, Texas (On-site) 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 Management Systems Specialist III is instrumental in implementing and maintaining an organizational-wide Quality Management System. This position works closely with the Supervisor of Quality Management Systems to develop, implement and maintain policies, procedures and systems to ensure compliance with internal procedures and current Good Manufacturing Practices (CGMP), and applicable regulatory standards. Additional responsibilities include the identification of deficiencies or gaps, developing solutions to ensure adequate and robust quality processes using root cause analysis, and optimizing workflows to comply with existing and new regulatory requirements. The ideal candidate must exhibit strong attention to detail, effective time-management skills to adapt to rapid business goals; strong organizational skills, self-motivated, and thrive in a fast-paced and dynamic environment. This role requires adaptability to change, and a commitment to fostering a culture of quality while making a meaningful impact at Velocity Bioworks. Duties & Responsibilities Maintain and administer the Training Program including conducting and coordinating employee training on applicable training curriculums and regulatory requirements. Participate in the development, implementation and continuously improvement of training programs for quality systems (e.g., GMP, GDP). Manage and maintain controlled documents, electronic forms and personnel training records within the company’s electronic quality management system (eQMS) and record retention location outside of eQMS. Create training curricula, assign training, track training completion and training activities for all personnel in the eQMS. Administer, track, and support the lifecycle management of nonconformances, deviations, investigations, and CAPAs within the eQMS. Collaborate with eQMS vendors and internal stakeholders to support system configurations. Provide publishing support for company documents in the creation of PDFs using eCTD format. Perform a quality review of controlled documents prior to release in the eQMS and verify the accuracy, correctness of formatting, styles, consistency and compliance with Velocity Bioworks’ document control standards. Perform risk assessments and facilitate control plans to prevent/resolve issues. Perform daily functions within the electronic document management system. Supports the maintenance, effectiveness and continuous improvement of quality systems processes, as needed. Review proposed changes impacting the validated state of quality systems through change control and coordinate review, implementation, and documentation of approved changes. Supports management review process through development, analysis and trending of quality systems metrics and elevate quality issues as required. Supports QMS representative during internal, client, and regulatory audits, supporting audit readiness, execution, and follow-up activities. Maintain and supports programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (CGMP). Author, review, and implement changes to controlled documents (e.g., SOPs, specifications, methods, and forms), as required. Provides guidance, technical expertise and mentorship to more junior staff and support oversight of assigned quality systems activities. Maintain the standards of ethical behavior and conduct to promote a quality culture within the organization and ensure the safety and reliability of finished goods manufactured by Velocity Bioworks. Perform other related duties as assigned in support of Quality Management Systems objectives. Requirements Education & Experience 4 to 5 years of experience with bachelor’s degree or a technical degree in health or medical field Working knowledge of GMP in conformance to U.S. standards (21 CFR 11, 210, 211, 600). Experience with the configuration and maintenance of electronic document management software. Experience with application of risk management principles, including identification, controls, mitigations, and actions preferred. Experience with Change Control practices/strategies. Experience using electronic document management software systems. Experience with internal and external audits is a must. Skills & Competencies Demonstrated excellent verbal and written communication skills, with the ability to clearly convey complex quality and regulatory concepts. Ability to operate effectively and independently in a dynamic and fast-paced environment managing multiple priorities. Must work collaboratively with multiple departments for efficient and timely completion of assigned tasks. Must have strong authorship and be able to critically review executed documents and protocols. Must be able to effectively prepare communications to management with clarity and a high level of accuracy. Strong organizational, problem-solving, and time management skills with attention to detail. Effective interpersonal skills, including the ability to influence, coach and support others while maintaining productive working relationships. Action-oriented and customer-focused mindset, with demonstrated strengths in planning, organizing, conflict resolution, and analytical thinking. Ability to work with moderate direction to complete complex assignments and minimal supervision on routine task; demonstrates a high degree of self-direction and accountability. Proficiency with standard business and quality software applications, including Microsoft Outlook, Word, Excel, PowerPoint, and Adobe Acrobat Professional; experience with electronic quality management systems. Physical Requirements & Working Environment While on-site performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus. The employee must have manual dexterity and manual ability to effectively use computer terminals. The position is primarily remote with requirements to be on-site occasionally. Flexibility is required for working hours. Some weekend work may be needed, and earlier or later start/finish times may also be required. 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 assigned agreement and approved engagement request with Velocity Bioworks, Velocity Bioworks reserves the right to pursue and hire those candidates 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. #J-18808-Ljbffr Velocity Bioworks