Corrective Action & Preventive Action (CAPA) Specialist

Title: Corrective Action & Preventive Action (CAPA) Specialist
Location: Wauwatosa, WI
Duration: 9+ months

Description: In this role, the CAPA & Documentation Specialist will assist the Site CAPA Leader with CAPA activities, Document Control, as well as Training Administration.

Daily Tasks/Key Responsibilities:
 • Ensuring regulatory compliance and optimization of quality system procedures relating to CAPA, complaint handling, adverse event reporting and product field actions through development, maintenance and improvement of documented processes, development and implementation of employee training
 • Leading/Supporting key QA/RA activities as assigned including CAPA investigations, Doc Control, and Training
 • Identify and report any quality or compliance concerns and take immediate corrective action as required
• Perform investigations and action plan activities to ensure timely closure
 • Collect and compile appropriate data and metrics for CAPA board reviews
• Provide direction and guidance to peers and subordinates to assist with their learning and effectiveness
• Bachelor's degree or Associate’s degree (or high school diploma/GED plus 4 years of related work experience).
• Ability to communicate effectively (both written and oral) in English.
• Prior experience using word processing, spreadsheet, and presentation software
• Minimum of 5 years’ experience in a medical device or pharmaceutical industry
• Minimum of 5 years’ experience with CAPA systems, including complaint handling
• Minimum of 5 years’ experience applying regulations (including FDA QSR, ISO13485)
Desired Skills/Background:
 • Energetic, team-oriented, and strong communication skills 
• Quality-focused, attentive to detail and results-oriented 
• Ability to identify root cause of problem, and creatively problem solve to gain resolution 
• Auditor Certification 
• Familiar with Continuous Improvement methodologies, including Six Sigma 
 • Experience with Training and course development

Thank you,
Sachin Patil
APN Software Services, Inc
39899 Balentine Drive, Suite 385, Newark, CA 94560
Phone: 510-402-1063 Fax 510-623-5055  

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