Quality System Specialist III

Job Code:




The Quality System Specialist III position will continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products.

Exercise judgment within defined Quality Assurance and Manufacturing procedures to determine appropriate action for resolution of manufacturing.


  • Monitor and review Quality Management Systems (Quality Systems, Audits, CAPA, Complaints, Device Tracking, Document Control, Software, Training, Metrics) and procedures to ensure and maintain compliance, strategies, and objectives for products, processes, and systems

  • Support and potentially lead efforts to assess and implement required Quality System changes and improvements through gap assessments, Quality Plans, remediations, and/or integrations

  • Contribute to the writing, coordination, review, approval and maintenance of the Quality Systems Procedures and documents

  • Host scheduled client audits and ad-hoc regulatory inspections, which includes drafting audit responses, tracking CAPA closure and outgoing communication 

  • Coordinates on-site client audits, preparation of audit materials, and ensure timely response and resolution to client observations, to include but not limited to; management of outgoing communication, audit document prep, and meeting logistics

  • Supports administration for CAPA, Investigation, and Deviation systems. Includes, facilitating the closure of items with the applicable departments to ensure completion and timely resolution

  • Responsible for tracking and trending aspects of the Quality System and provide reports to management identifying risks and trends on a routine basis.

  • Prepare functional and Management Review metrics for identification of negative trends. Conduct analysis of identified negative trends and propose/implement necessary corrections to address and present to Management team Manage, and lead internal audit program which includes creating annual schedule, creating audit agenda, drafting audit reports, tracking CAPA closure and drafting outgoing communication

  • Facilitate risk assessments for site using applicable tools (FMEA, HAACP, etc.)

  • Maintains tracking mechanisms to support various Quality Systems elements and ensures visibility throughout the organization

  • Other responsibilities as assigned


  • Minimum of a B.S. in a Life Sciences discipline. 

  • +6 years’ experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry and +4 years’ experience in Quality / Compliance function

  • SQ (American Society of Quality) or RAPS (Regulatory Affairs Professionals Society) highly desirable