Quality Specialist

Company Description

Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA.

Group's key figures are approx. 6.7 billion Euros turnover, over 900 laboratories across 61 countries and about 61,000 staff.

Job Description

The Local Quality Specialist receives sufficient authority from, and is directly accountable to the local Deputy Quality Manager for the successful completion of assigned duties and responsibilities and has the authority to take action necessary to carry out the duties and responsibilities of this position and to identify the occurrence of departures from the quality system or from the procedures for performing tests and/or calibrations, so long as such action does not deviate from established company guidelines, is consistent with sound technical and business judgment, and follows the practices of the laboratory. The Local Quality Specialist will be responsible for supporting the operational and technical supervisor in ensuring timelines and quality measures are met and technicians are on task in accordance with the specific quality tasks to which they are assigned.

• Understand and follow Quality System documents relevant to responsibilities, e.g., Quality Manual, SOPs, and Methods.
• Acts as a resource for laboratory personnel for correct application and interpretation of internal quality documents relevant to their assigned tasks.
• Responsible for assisting in annual 17025 Self-audit as well as method audits and generating non-conformances as a result of audit.
• Responsible for ensuring non-conformances and complaints are documented via the electronic tracking system and that timeliness requirements are met. Monitor non-conformances, root cause analysis, and complaint resolutions for trends.
• Responsible for ensuring equipment calibration schedules are maintained.
• Responsible for ensuring training documentation is completed in a timely manner and maintained.
• Responsible for testing sample traceability and documenting the results of sample trace back exercises.
• Responsible for corporate quality projects as assigned.
• Identify process difficulties and report these together with proposed solutions to supervisor.
• Maintain a perpetual state of readiness and willingness to respond to the queries and needs of clients, staff, and co-workers.
• Maintain a cooperative working relationship with lab operations to ensure daily, weekly, monthly quality tasks are completed and reviewed in a timely manner.
•  Maintain cooperative working relationships with all company employees. Communicate orally and in writing to co-workers. This includes “intra” and “inter” departmental employees.
• Promote the company image through the exercising of sound and ethical business practices as related to the public and our customers.
• Other duties as assigned.

Qualifications

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily.  The requirements below are representative of the knowledge, skill or ability required:

• demonstrable attention to detail
• knowledge of GxP preferred
• knowledge of microbiology techniques an advantage
• understanding of basic statistics
• intermediate to expert MS Office suite skills
• high integrity, excellent communication, conflict resolution
• English language skills
• BS Degree plus 1+ years’ laboratory experience
• Previous experience in a production style laboratory preferred. Prior experience working with a variety of regulatory guidelines (ISO) and QC/QA programs an advantage.
• Excellent interpersonal and communication skills.
• Excellent organizational skills with excellent attention to detail.
• Self-motivated and driven critical thinker able to work in high pace and rapidly changing environment.
• Responsive problem solver and action oriented.
• Authorization to work in the United States indefinitely without restriction or sponsorship

Basic Minimum Qualifications: 

B.S. or A.S. in a life/bench science field

2-3 years in a QA/QC role

1-3 years Laboratory experience

Additional Information

Position is Full Time, 1st Shift, M-F 9am - 6pm

 Candidates currentl