Quality Systems Specialist
Eurofins

Job Info

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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, 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 for supporting clinical studies. In addition, Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing.

In 2018, Eurofins generated 4.2 billion Euro proforma turnover in 800 laboratories across 47 countries, employing about 45.000 staff.

Eurofins stands for a conception of clinical diagnostics entirely focused on excellence, innovation and technological investment. Eurofins clinical diagnostics offers testing services in all medical specialties.

As a central element in healthcare, clinical diagnostics contributes to every stage of patient care: predisposition, prevention, diagnostics, treatment monitoring and prognosis.

With hundreds of thousands of clinical diagnostics tests performed every day, the laboratories of the clinical diagnostics division strive to ensure that every patient, wherever he or she lives, has access to the most specialized and most innovative techniques for diagnosis, monitoring and therapeutic adjustment. Our logistics expertise and our daily sample collection and delivery network, guarantee perfect continuity in the provision of care while ensuring the same standard of quality and access to innovation across all the regions we serve.

Job Description

Quality Systems Specialistresponsibilities include, but are not limited to, the following:

• Under the direction of the Manager of Regulatory Affairs and Quality Assurance, this position will assist with maintenance of the Eurofins CellTx Quality Management System (QMS).
• Initiate, investigate, close, track, trend and verify effectiveness of actions with the QMS components, such as quality events (including deviations, complaints, nonconformances, and investigations), audit corrective action records (ACARS), and Corrective and Preventive Actions (CAPAs). Identify high level trends that have an impact to the organization and escalate the issue/incident appropriately.
• Lead and/or assist in representing Eurofins CellTx with hosting external auditors (client and regulatory-based audits). Provide external auditors with requested information, ensure documentation is complete and accurate, and collaborate with operational staff for tours and interviews.
• Assist with facilitation of the licensing, accreditation, and/or certification process.
• Provide training and support to inter and intra departmental employees. Lead and mentor employees with the various Quality System elements; Assist in New Employee Orientation programs, organizational-wide training, and individual training for elements, including, but not limited to: Good Documentation practices (GDP), Manufacturing, Tissue Practices, QMS components, applicable regulatory standards, annual procedure review, Document Control, Record Review/ Record Management, Training Program elements and customer satisfaction.
• Assist and facilitate in the development of planned and systemic processes for Continuous Quality Improvement (CQI) throughout the department and organization. Assist in developing long range continuous improvement plans to accomplish quality; evaluate and provide suggestions to improve system efficiencies and effectiveness.
• Develop and monitor relevant Quality Indicators for the Quality System to be used an input into the Quality Management Review process.
• Serve internal and external customers as a consultant. Assist management in addressing business needs in quality or regulatory areas by guiding identification of cause, finding best solution, supporting implementation and monitoring.
• Perform duties and tasks in a timely and compliant manner, ensuring accurate documentation and conclusions.
• Maintain and utilize sound working knowledge of all program regulations, standards and policies; keep current with all relevant federal, state and local regulations, recalls, and guidance.
• Ensure all established procedures (OPs, methods, etc.) and regulatory standards are adhered to at all times. Develop or revise standard operating procedures and laboratory policies, as applicable.
• Assist in organizing and facilitating regularly scheduled training with managers, supervisors, team leaders and staff as needed to educate/ collaborate and implement quality principles and corporate compliance as a strategy.
• In order to meet Eurofins's quality policy and goals/objectives, all employees are expected to meet basic expectations of Eurofins's quality management system including, but not limited to good workmanship, adherence to standard operational procedures, training,good documentation practices, and accurate recordkeeping.
• Exhibit support of Eurofins CellTx' business philosophy, leadership values, quality objectives, ethical behaviors, customer care and confidentiality standards at all times. Foster a positive work environment, modeling professional behavior.
• Other duties as assigned, when necessary

Qualifications

Minimum Educational Qualifications:

• Highschool Diploma
• Associates degree in a healthcare, business or related field or Bachelor degree in Life Science preferred

MinimumQualifications:

• Minimum 1-3years of quality, laboratory and/or regulatory experience in a regulated industry
• Experience with regulatory and/or accrediting agencies (e.g. FDA, ISO, AABB, CLIA) preferred
• Ability to work effectively under the expectations of Quality System expectations
• Willing to travel to satellite locations for quality support, internal audits and regulatory inspections (≤25% travel)
• Quality Auditor certification (ASQ or equivalent) desired
• Advanced analytical and problems solving skills
• Computer skills in Word, Excel, e-mail required. Database management and/or development skills helpful but not required
• Ability to work in controlled environments
• Highly developed organizational and multitasking skills
• Possess a high level of integrity (professional, diplomatic, confidential) with demonstrated interpersonal skills with the ability to interface well with employees with other departments (and within the QA department)
• High level skills in oral and written communications
• Authorization to work in the United States indefinitely without restriction or sponsorship

Potential Environmental Factors:

• This laboratory carefully maintains all hazardous materials. All employees must abide by Eurofins CellTx' Safety and Exposure procedures. This includes using the provided safety clothing and equipment
• For a list of potential chemical hazards, see appropriate SDS sheet

Additional Information

Position is full-timeworking between Monday - Friday 9:00am - 5:30pmwith overtime as needed. Candidates currently living within a commutable distance of Tucson, AZ are encouraged to apply.

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

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

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