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This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/12902217

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Basic Function and Scope of Responsibility:

The position is primarily responsible for Quality Management System (QMS) activities and compliance with applicable regulatory requirements by ensuring the effectiveness of the QMS in meeting its stated goals and objectives. This position is also responsible for the management and maintenance of the electronic document management system, training and competency, and other systems and processes including training staff on document control processes and procedures. This position will manage both paper and electronic records to ensure that controlled records are created, identified, changed, reviewed, retained, stored, and maintained in a manner that meets requirements. This position will support the laboratory with maintaining CLIA and other state permit accreditation, where applicable.

Qualifications

Essential Job Duties:

Level I - Minimum

• Support, maintain and continually improve the QMS
• Assist team members with and/or perform internal audits and inspections of the QMS for compliance assessment which may include, but is not limited, to BioPharma and Clinical study work and records, study reports, laboratory method SOPs, and other quality records, processes, and activities ensuring Good Documentation Practices (GDP) is being adhered to
• Assist with external audits or quality surveys performed by regulatory/inspection agencies and clients such as pharmaceutical companies or Clinical Research Organizations (CROs)
• Assist with maintenance of overall document control structure within an electronic document management system
• Assist with defining and maintaining user roles and permissions in electronic document management system
• Assist with storage, indexing, and classifying controlled records
• Assist management with the compilation of audit findings for both internal and external audits
• Administer regulatory binder documentation system, assigning and numbering binders, tracking, and archiving; order and control access to adequate stock of regulated binders
• Maintain familiarity with laboratory operating and quality assurance/quality control procedures to effectively perform laboratory quality assurance functions
• Support new hire orientation
• Support development of system and process improvements that would enhance compliance to documentation/training requirements
• Represent department and the organization favorably and in accordance with established company standards and associate attributes at all times
• Participate in developing department goals, objectives, and systems
• Assist with other administrative duties as assigned/required

Level II - Fully meets the responsibilities of Level I plus the following:

Discuss audit and inspection findings with management to develop appropriate corrective and preventive actions where appropriate

Understand and demonstrate proficiency with quality monitoring activities such as quality indicators and quality reporting

Advise and assist management on QMS development and review

Ensure policies and procedures are monitored and updated to include regulatory change

Oversee Document Management activities that include trainin