CovarsaDx

Marisa Meeks

Quality Assurance, Technical Writer

Marisa Meeks currently consults as a Quality Assurance Associate and Technical Writer at CovarsaDx. Her principal responsibilities are to develop and implement clinical grade quality assurance procedures and ensure company compliance with regulatory requirements and policies. She also writes and develops clinical-grade study materials, user manuals, and other informative communication materials.

She completed the ISO 13485:2016 Lead Auditor Training certification course in February 2022. Marisa held a part-time position at Hycor Biomedical as a Senior Quality Assurance and Technical Writer.

In the area of quality assurance, her core competencies include conducting internal quality audits, reviewing and approving study-related documentation, developing and maintaining quality metrics to measure the quality management system’s effectiveness, and identifying improvement areas. Marisa has successfully led investigations and root-cause investigations to identify and resolve quality issues. She also reviews and approves corrective and preventive actions (CAPA) and participates in internal and external audits and inspections.

Her technical writing responsibilities extend to a deep collaboration with cross-functional teams, including clinical research associates, data associates, and more, to ensure documentation accuracy. She also edits, proofreads, and revises key technical documents to ensure accuracy, consistency, and quality. Her experience in documentation project management has helped clinical companies complete priority tasks with the utmost quality and compliance with regulations and policies.
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