Quality Compliance Specialist (CAPA & NCR Writer)

About the Role Join a dedicated team of quality professionals committed to maintaining the highest standards in healthcare manufacturing. As a CAPA/NCR Writer, you will play a critical role in our quality assurance process, investigating deviations and implementing corrective actions that impact patient safety and product integrity. This is an excellent opportunity for an analytical problem-solver to work in a high-impact, audit-ready environment.

Key Responsibilities
Lead thorough investigations into non-conformances (NCR) using the TrackWise 8 Management System.
Develop and execute Corrective and Preventive Action (CAPA) plans to mitigate future risks.
Act as a subject matter expert for regulatory requirements, ensuring the facility remains in a constant state of audit-readiness.
Collaborate across departments to perform DMAIC problem-solving and process improvement projects.
Provide coaching and guidance to plant personnel on quality standards and regulatory compliance.

Qualifications
Education: Bachelor s Degree in Science, Engineering, or a related technical field.
Experience: 2-4 years in a cGMP-regulated industry (Medical Device, Pharma, or Clinical).
Technical Skills: Proficiency in TrackWise and a strong understanding of FDA/International regulatory requirements.
Problem Solving: Familiarity with Six Sigma or Lean tools (Greenbelt certification is a significant plus).
Communication: Exceptional technical writing skills and the ability to present findings to management.
Physical Requirement: Due to the nature of the production environment, candidates must not have allergies to Penicillins or Cephalosporins.