Senior Quality Assurance Specialist

3 weeks ago


Étreux, Hauts-de-France, United States Foundation Medicine Full time
Job Overview

We are seeking an experienced Senior QA Specialist, Document Control to join our team at Foundation Medicine. This role plays a critical part in ensuring the quality and compliance of our document control processes.

About the Job

This position will be responsible for leading programs, mentoring peers, developing and implementing regulation-adherent processes, and driving process improvements to further enhance quality functions, formalized procedures, operations, and systems.

Responsibilities
  • Leverage expertise to lead electronic Document Management System (eDMS) Veeva Vault implementation and maintenance.
  • Coordinate all aspects of eDMS operation, including controlled issue retrieval, archiving, and regulated documents support.
  • Support new product development document creation projects, formatting, editing, and collaborating with teams.
  • Maintain quality and detail in creation/management of documents, technical word-processing/editing of SOPs, and other documents.
  • Responsible for maintaining, updating, and versioning policies and procedures, forms, and records.
  • Perform document quality checks on all controlled documents.
  • Coordinate periodic review management for required documents within the eDMS.
  • Assist document owners in creating documents and workflows in eDMS.
Requirements
  • Bachelor's degree or related field with 5+ years experience in medical device, diagnostics, clinical laboratory, or biopharmaceutical industry - preferably in QA environment.
  • Associate's degree in science or related field with 7+ years experience in medical device, diagnostics, clinical laboratory, or biopharmaceutical industry - preferably in QA environment.
  • High School Diploma or General Education Degree with 9+ years of strong experience in medical device, diagnostics, clinical laboratory, or biopharmaceutical industry - preferably in QA environment.
Preferred Qualifications
  • Experience working with electronic document management and quality management systems highly preferred.
  • Previous Document Control or Record Management experience required.
  • Exposure to regulatory compliance knowledge including GMP, ISO 13485, ISO 15189, CAP/CLIA, NYS, states, GCP, IVDR, and 21 CFR Part 11 Compliance.
  • Demonstrated ability to lead teams and mentor staff.
  • Ability to multitask within specified timelines.
Estimated Salary

$120,000 - $180,000 per year.



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