Quality Management Systems Specialist

Where

Tarrytown, NY

What you'll be doing

Compiles and assesses QAA metrics to identify trends and opportunities for improvement on a monthly and quarterly basis. Assist in/lead investigations for QAA deviations ensuring identification of root cause and associated corrective/preventive actions. Provide guidance/training to QAA personnel on investigation/problem solving and root cause analysis techniques. Assist in/lead continuous improvement projects/initiatives. Assist in analysis and triage of Regulatory Intelligence (D-RISC) documents for impact to the QAA functional areas. Point of contact for creation of departmental metrics presentations. Assists with development of QMS Trending Reports. Maintains and performs review of information entered into the QAA deviation and CAPA trackers. Issues deviation numbers and respective due dates and monitors due dates to ensure visibility and on-time completion. Monitors the continuous improvement tracker and project tracker ensuring QAA Staff awareness of due dates, escalation of issues, and issuance of metrics. Develops and issues weekly QAA QMS Status communications, action item status updates, and monthly CAPA customer notification.

What your background should be

5+ years of related work experience required. Knowledge of and experience with quality management systems and continuous improvement methodologies (e.g. Lean, Six sigma). ASQ Green belt or equivalent desirable. Strong interpersonal and project management skills. Ability to communicate effectively. Ability to manage multiple tasks and ensure on-time completion. Working knowledge of MS Word, XL, PPT, and Access.

Required Schooling / Training

BS degree required.

Who is the client company

This is a biotechnology company.

If you are interested in this position, send your resume to apply@kochdavis.com