Quality Systems Specialist
Reporting to the Director of Quality, the Quality Systems Specialist participates all aspects of establishing, implementing, and maintaining the Quality Management System (QMS) at Quad Technologies. The position coordinates with R&D, Quality control, and Operations to ensure the QMS is kept current and is efficiently and properly maintained. As such, the individual must be familiar with the QSRs (21 CFR Part 820) and knowledge of cGMP (21 CFR Parts 210 and 211) is a plus. The individual must be able to prioritize activities associated with timelines and risk management from a quality perspective.
Essential Duties and Responsibilities:
• Work in a fast-paced environment, assessing and managing dynamic priorities inherent in both clinical development programs and commercial supply.
• Work cross functionally across Quad with key department heads in R&D/CMC, Quality Control, and Operations to implement and maintain QMS programs.
• Actively assist in creating, implementing, and maintaining the QMS at Quad Technologies, including writing the applicable SOPs, identifying required metrics for various programs, and interfacing with vendors to facilitate vendor management.
• Monitor QMS metrics, identify issues/root causes and develop any required resolution plans.
• Track outsourced Quality Control samples and results
Education and/or Experience:
• Bachelor’s degree in a scientific or health-related field required.
• Minimum of 3+ years of Quality Assurance experience in the biotechnology or pharmaceutical industries expected.
• Solid foundational understanding of cGMP principals in biotech, medical device, or pharmaceutical manufacturing.
Other skills and abilities:
• Ability to interact effectively with all levels of personnel within the organization.
• Ability to serve on multiple interdepartmental teams and to act as team leader when appropriate.
• Demonstrate strong organizational and interpersonal skills, building relationships with effective communication, influencing, conflict resolution, critical thinking, and problem solving with a keen attention to detail.
• Strong aptitude with Microsoft Office products (Word, Excel, etc.)