Mia G.

About Mia G.

Resourceful and research-oriented quality control specialist with a combination of…

Experience

1. Capa Specialist

   MiMedx

   Sep 2022 — Present

   Ensure company-wide adherence to all internal and external regulations and policies through routine audits of processes and procedures. • Identify areas of non-compliance and assign corresponding action plans in order to correct the observations. • Manage the deviation, investigation, and non-conformance reporting systems and corresponding corrective and preventive action files. • Assist in completing investigations, documenting quality impact, identifying root causes, and assigning corrective and preventive actions to responsible parties. • Assist in reviewing and maintaining cleaning logs and Assist in the functions of the product packaging system.• Enforce company-wide compliance to quality system standards, operating procedures, training requirements, safety practices, company policies, and regulatory requirements.• Perform walk-throughs/audits of company-wide operations (e.g. tissue recovery, tissue check-in, inspection of raw materials, processing, analytical testing of finished product, packaging, distribution, etc.); maintain and document results.• Identify areas of deficiency/potential adverse impact, conduct internal investigations and root cause analysis/impact on product, determine corrective/preventive action, and document activities of continuous improvement.• Manage and track deviations/investigations to ensure timely completion; manage open corrective actions/open reports, conduct effectiveness checks, route investigation files for approval, file completed records, etc.• Prepare and maintain the annual internal audit schedule; assist with regulatory audits by providing documents, procedures, information, etc.• Conduct new hire and ongoing training on the CAPA system, and maintain up-to-date training files.• Assist in the functions of maintaining the product packaging system; perform label verifications, proofing process, and maintain document results.• Assist in compiling and analyzing quality metrics of the Quality Management System.