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Specialist, Data Analysis and QC
4 weeks ago
Our client, a leading global CDMO, is looking to hire a QC Deviation Specialist III to join their growing team in Greene County, Missouri
Job type : 4-month contract (possibility of extension)
The QC Deviation Specialist III will be responsible for leading and executing quality investigations, including deviations and OOS events, within Manufacturing and QC departments. This role ensures compliance with internal procedures, regulatory requirements, and industry best practices while driving continuous improvement through effective root cause analysis (RCA) and implementation of corrective and preventive actions (CAPAs).
Perform and document Deviation Investigations for Manufacturing and Quality Control operations.
Conduct Root Cause Analyses (RCA) and determine appropriate Corrective and Preventive Actions (CAPAs) to address identified issues.
Partner with Manufacturing, QC, and Quality Assurance teams to support investigations and ensure timely and compliant closure.
Provide coaching and training to staff on deviation investigations, RCA methodologies, and investigator qualification.
Perform and draft Out-of-Specification (OOS) investigations in accordance with internal policies and regulatory standards.
Review and analyze data to identify trends, recurring issues, and opportunities for process improvement.
Support continuous improvement initiatives within the Quality Management System (QMS).
Ensure all activities comply with applicable GMP, ISO, and regulatory requirements.
Minimum 10 years of relevant experience in Quality Systems Management, with direct experience in manufacturing and quality control deviation management.
Strong knowledge of Root Cause Analysis (RCA) and CAPA development and implementation.
Proven experience writing and managing quality investigations in a regulated industry (e.g., pharmaceutical, biotechnology, medical device, or similar).
Bachelor’s degree preferred in a scientific, engineering, or related technical discipline.
Familiarity with Good Manufacturing Practices (GMP) and regulatory guidance (e.g., Experience using electronic quality systems (e.g., Prior experience mentoring or training personnel on deviation and CAPA processes.
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