Quality Management Systems Specialist III

About the role

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.

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.
• 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.
• Supports the maintenance, effectiveness and continuous improvement of quality systems processes, as needed.
• Supports management review process through development, analysis and trending of quality systems metrics and escalate 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.

Requirements

• 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
• Able 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
• 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