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QA TECHNICIAN

Location: Firenze, Italy
Position Type: Unfixed Term

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux conceives, develops, produces and markets diagnostics solutions (systems, reagents, software and services) intended for clinical and industrial applications, which determine the origin of a disease or a contamination to improve the health of patients and insure consumer safety.

bioMérieux is present in 44 countries and serves more than 160 countries with the support of a large network of distributors. Its corporate headquarters are located in Marcy l’Étoile, near Lyon, in France.

Joining bioMérieux is choosing to be a part of an innovative company with a long term vision, committed to the service of public health and carried out with a human-centered corporate culture.

Our Company offers numerous opportunities for professional development. You want to  help save lives across the globe? Join the 13,000 employees of bioMérieux!

 

 

 

QA TECHNICIAN

 

The Quality Assurance department provides Quality support across various departments within bioMérieux Italia S.p.A.. The individual may review quality records, inspect manufactured products and raw materials, perform calibration and preventative maintenance on tools and equipment, and/or maintain Quality system documents and records. Timely and accurate work is expected.  This position regularly interacts and collaborates with other departments within bioMérieux Italia manufacturing site and other group sites. The individual performs all work in compliance with company policy and within the guidelines of bioMérieux Quality System. As a Quality representative, candidate will be responsible for reviewing, assessing and monitoring process and product to ensure compliance to requirements

 

 Main Accountabilities

  • Verify documentation (DHR Review) and upload results to bioMérieux company group Quality System.
  • FilmArray Repair Service

  • Follow work instruction documents to ensure batch record compliance
  • Perform visual inspection on completed instruments
  • Provide support for compliance of preventative maintenance and calibration requirements of manufacturing equipment.
  • Identify any/all non-compliance to batch records, work instruction documents, and calibration requirements
  • Alert manager of nonconforming events
  • Incoming Inspection
  • Perform inspection of incoming materials using basic measurement tools
  • Perform quarantine activities including physical and electronic segregation, labeling, physical and electronic release
  • Initiate NCs with measurement criteria and failure details
  • Perform dimensional and/or functional inspection on machined parts to verify conformance of parts to prints, process plans and specifications.
  • Comparison of defined aspects of physical materials to written specifications to determine compliance.
  • Determine suitability of manufactured materials for release to manufacturing

 

Typical Studies-Experience, Skills and Qualifications

  • High school diploma or equivalent is required
  • Associates degree in life science or engineering discipline preferred.
  • Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and 21 CFR 820 preferred
  • Work experience in a laboratory or life science manufacturing setting that has a formal quality system is preferred
  • Minimum 2 years previous on-the-job experience requiring professional communication and interactions with other people and department’s representatives.
  • Any experience in Quality Assurance or Quality Control preferred.
  • Effective written and verbal communication skills
  • Proficiency in MS Office tools, including Outlook, Word, and Excel
  • Attention to detail is fundamental to this position
  • Organization as needed to maintain paperwork and task schedule

 

 

 

 

 

Working at bioMérieux means being involved long term with a pioneering, visionary and constantly growing company that allows its employees to live a stimulating and inspiring experience in a fulfilling work environment

Our internal mobility policy offers numerous opportunities for each of our 13 000 employees to blossom throughout their career, while respecting each employee’s individual talents as well as their personal and professional development.

At bioMérieux, over 200 professions - both scientific and non-scientific - offer our employees the opportunity to broaden their fields of expertise and develop cross-functional careers. We provide a rewarding experience in an international company that brings together talents from diverse backgrounds, thus fostering a daily aspiration to go beyond the limits.

Helping improve public health around in the world : our mission gives purpose to every profession practiced within the company.

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.

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