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 works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics 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, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

 In 2019, Eurofins generated total revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.

1) QA

• Collaborate with other members of management to formulate and establish quality and regulatory compliant policies/procedures/goals for the company business.
• Develop, optimize, manage, and implement the Quality Management Program (as per Quality System Essentials (QSE) and CAP/CLIA/NYSDOH). Establish and maintain policies and procedures to ensure compliance with government regulations and ensure staff training.
• Lead the Quality Committee meetings with quality team and department heads to establish and optimize procedures, policies, functions, and operations between departments to attain quality goals. Ensure continual optimization of the lab’s key performance indicators, so that quality monitoring is relevant and effective in attaining patient safety in all lab processes.
• Proficient in data collection, assessment, statistical analysis tools to monitor QA indicator measures. i.e. Access, Excel
• Be company resource for all quality and regulatory clinical laboratory questions.
• Manage/perform internal audits; this includes collaborating with lab departments, analyzing information to identify trends in findings of non-compliance and defects, participating in the development/implementation of corrective actions, and completing audit reports.
• Establish and maintain compliance with all required external regulatory licensure agencies, manage site inspection by agencies, and facilitate/complete inspection responses. Complete routine, new, and change notification correspondence regarding regulatory filings and licensure.
• Manage Risk Management / Corrective Action (CAPA) program; tracks deviations throughout the laboratory, including environmental monitoring and critical utility investigations.  Drives the use of process improvement tools including root cause analysis, error and trend analysis, and other applicable evaluation tools.
• Manage electronic Document Control and Competency management systems in MediaLab software application to ensure up-to-date users in system, appropriate procedure/policy training and lab-performed competency assessments are conducted in compliant manner.
• Demonstrated success in communicating effectively with employees, contractors, management, and regulators

2) EHS 

• Develop, optimize, manage, and implement the EHS Program, including but not limited to bloodborne pathogen exposure control, chemical hygiene, biohazard risk assessment, hazard communication, PPE, fire prevention, spill prevention, emergency response, and hazard waste management.
• Write and review/revise EHS Program policies and procedures on a routine basis to ensure compliance with required and accepted practices.
• Oversee the EHS company training program to ensure all personnel receive training as required and ensure it is updated as required to meet regulatory requirements.
• Perform EHS audits/assessments, write reports, and conduct all follow-up actions.
• Actively plan, assess, and complete corrective actions identified through accident/incident investigations or program audits/assessments.
• Perform workplace biohazard risk assessments for current and future laboratory processes.
• Serve as key point of contact and resource for all safety needs and questions.
• Lead the company safety committee. 
• Responsible for completing all EHS licensing/permit paperwork and interfacing with all EHS regulatory agencies.
• Responsible for managing onsite safety consultants.
• Actively engage and drive the entire employee population to promote a culture that is committed to safety compliance.

Minimum Qualifications and Skills 

·       Bachelor (BS, BA) in clinical laboratory sciences area or related field. MS in Quality or related field a  plus.

·       8-10 years of quality management and regulatory compliance experience in a CLIA certified laboratory, commercial laboratory experience preferred. (CLIA, CAP, ISO 15189, GMPs and/or NYSDOH).

·       ASCP, NCA or equivalent, certification which meets CLIA criteria

·       Certification in Auditing or Quality principals such as CQE, CQA a plus.

·       Demonstrated ability to interpret and communicate quality requirements to others.

·       Must be capable of prioritizing responsibilities and completing tasks on schedule and contribute positively in a team environment 

·       Effective meeting skills, both as a meeting leader and participant.

Ability to effectively manage, mentor and train others in quality systems and process improvement

Preferred Qualifications and Skills

·       NYSDOH licensing experience

·       Basic process improvement training and skills, e.g., Six Sigma or similar

·       Advanced Microsoft Office required – Access, Excel, Visio, Project, PPT

·       Document Control Software skills required, e.g., MediaLab

Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed. 

As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work.  We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options.

To learn more about Eurofins, please explore our website www.eurofinsus.com.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.