Meridian Bioscience

RA/QA Documentation Specialist

Job Locations IT-Villa Cortese, MI
Company
Meridian Bioscience Europe
Department
Quality & Regulatory Affairs
# of Openings
1

About Meridian

Meridian Life Science, a segment of Meridian Bioscience, is a first-choice solution provider of innovative immunological and molecular raw materials that accelerate discovery and diagnostic assay development. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, novel solutions to tough problems

Job Summary

The role of RA/QA Documentation Specialist is an integral part of the QA/RA team and of the entire Company.
The RA/QA Documentation Specialist is expected to provide a significant support in the development of new documents, procedures, and changes to existing procedures, processes, plans, and other quality system and regulatory documentation according to the quality and regulatory requirements.

Key Duties

  • Coordinate, develop, and maintain quality system documents and technical files: formatting
    documents, reviewing and updating of documents, assigning approvals, producing effective
    documents, documentation control.
  • Own the documentation system such that reports, statistics and performance data can be produced.
  • Ensure integrity of all QA files for the purpose of efficient and timely retrieval of generateddocuments
  • Carry out audits of the documentation system
  • Assist in the updating of documents as requested
  • Collaborate to perform internal audit and write audit reports
  • Record, maintain and get reports for the CAPA system
  • Record, maintain and get reports for the PMS system
  • Participate in the maintenance and continuous improvement of the quality system.
    Knowledge, Skills and Abilities:
  • Organizational skills
  • Highly motivated, details and focus oriented
  • Versatility, flexibility and willingness to work with changing priorities
  • Ability to work in a rapidly changing environment
  • Ability to handle multiple projects and meet deadlines, working closely with the all the company’s teams
  • Must be aware of ISO 13485 Quality System Requirements
  • Must be aware of CE Mark Requirements
  • Must be aware of ISO 14971 Risk Management for Medical Devices
  • English, verbal and written
  • Strong IT skills, including Microsoft Office Suite.

Qualifications

  • Scientific Degree or equivalent 
  • Quality and Regulatory Knowledge acquired with a minimum 2 years of experience or equivalent in the Quality and Regulatory field.
  • A post-degree in Regulatory Affairs or equivalent is a plus

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