Quality Assurance Specialist
Eurofins

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

• Collecting details from cross-functional departments to author change controls for components and raw materials
• Entering change controls into electronic system (QTS) and routing to departments for assessments
• Tracking and project managing the assessment completion
• Routing the change control for approvals
• Tracking and project managing approvals
• Tracking task completion associated with approved change control and working with owners to ensure tasks are completed by assigned due dates
• Entering new enrollment tasks into electronic system (QTS) and assigning task owners
• Extending enrollment due dates when needed
• Adhere to site SOPs and cGMPs for production activities in the manufacturing facilities
• Adhere to site safety standards, participate in routine safety training events, and enforce safety and biosafety requirements as they relate to the Clinical Manufacturing department

• Bachelor's degree in a scientific or engineering discipline or similar, with a minimum of 1-2 years GMP experience
• Knowledge of pharmaceutical supply chain or QA experience preferred
• Strong computer skills; specifically Excel and SAP
• Organization/project management skills
• Able to work both independently and as a member of a cross-functional project team in a fast-paced environment
• Authorization to work in the United States indefinitely without restriction or sponsorship
• Valid driver's license and personal transportation

• Position is full-time, working Monday-Friday 8:00 a.m.-5:00 p.movertime as needed
• Candidates currently living within a commutable distance of Durham, NC 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
• #LI-EB1

• Authorization to work in the United States indefinitely without restriction or sponsorship