Quality Specialist - On Site
RXinsider LTD.
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 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 is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins 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. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. 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. In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description The Quality Specialist provides operational support for the Quality Management System, supporting compliance with ISO 17025 and other applicable standards through documentation control, audit readiness, record management, and routine quality assurance activities. Understand and follow Quality System documents relevant to responsibilities, e.g., Quality Manual, SOPs, and Methods. Act as a resource for laboratory personnel for correct application and interpretation of internal quality documents relevant to their assigned tasks. Help prepare, revise, and maintain controlled documents, including SOPs, work instructions, forms, and templates. Maintain training matrix records, follow up on overdue training requirements, and support onboarding by preparing training materials for new technicians. Help collect and compile local quality metrics on a monthly basis. Assist in managing proficiency testing orders, monitoring completion status and submission, and assist with proficiency testing outlier investigations. Review routine quality records for completeness, accuracy, and compliance. Support preparation and characterization of control materials and maintain associated data. Help maintain calibration schedules, coordinate calibration and maintenance service visits, and ensure equipment records and verification logs are complete and current. Assist with non-conformance investigations, perform root cause analysis, and develop, implement, and verify corrective actions. Conduct effectiveness checks, support retesting investigations, monitor complaint and nonconformance resolution, and elevate systemic quality risks. Assist with preparation for internal, external, and accreditation audits by gathering records and supporting documentation. Support the tracking and closure of audit-related action items. Maintain supplier and subcontractor records and support qualification and monitoring activities. 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. Requires occasional domestic travel (up to 5-10%) to other Eurofins sites. Other duties as assigned. Qualifications Education/Experience (BMQ): Bachelor’s degree in Chemistry, Food Science or related scientific field Minimum 1-3 years of experience in quality assurance or a laboratory role. Intermediate to expert MS Office Suite skills Additional Preferences Prior experience working with a variety of regulatory guidelines (ISO) and QC/QA p & GxP programs. Other Skills Excellent interpersonal and communication skills. Strong organizational skills with exceptional attention to detail. Self-motivated and action-oriented, with the ability to manage multiple priorities in a fast-paced environment Strong problem-solving and critical-thinking skills. Demonstrable attention to detail. Knowledge of chemistry techniques an advantage Understanding of basic statistics Excellent written and verbal English communication skills Additional Information 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 a M/F, Disabled, and Veteran Equal Employment Opportunity and Affimative Action employer. Eurofins USA Food Testing is a Disabled and Veteran Equal Employment Opportunity employer. #J-18808-Ljbffr RXinsider LTD.
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