Summary: The QA CAPA Consultant role involves managing the Corrective and Preventive Action (CAPA) process within the Quality & Regulatory organization, focusing on issue identification, root cause analysis, and ensuring compliance with quality standards. The position requires strong project management skills and a thorough understanding of CAPA processes in life sciences and defense sectors. The consultant will also contribute to continuous process improvement and represent CAPAs during audits. This is a long-term contract opportunity with remote working arrangements.

Key Responsibilities:

• Project Manage all CAPA activities from initiation to closure, ensuring timely and effective execution.
• Identify and assess issues, ensuring accurate documentation.
• Review CAPA data sources and assist with root cause analysis and quality problem solving.
• Participate in and/or lead root cause analysis activities to identify underlying causes of issues.
• Ensure the quality and completeness of CAPA records.
• Support and prepare spokespersons in representing CAPAs during audits and CAPA Review Board meetings.
• Perform timely, detailed CAPA engineering tasks like assessing issue descriptions and reviewing CAPA data sources.
• Contribute to the continuous improvement of CAPA processes and procedures.
• Ensure that products meet the highest standards.

Key Skills:

• CAPA process knowledge (Life Sciences & Defense).
• Strong solution designing and tech presales experience.
• Root cause analysis (5 Whys, Fishbone, FMEA, DMAIC).
• Audit readiness and compliance (FDA, ISO 13485, AS9100, GMP, EU MDR).
• Quality management systems (TrackWise, MasterControl, Agile PLM).
• Security and confidentiality compliance (DFARS, ITAR, GDP).
• Quality assurance and quality management expertise.

Salary (Rate): undetermined

City: undetermined

Country: USA

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: undetermined

Industry: Other