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.

The Specialist is responsible/accountable for Incoming Quality activities, including:

• sampling and inspection of raw materials/components in support of manufacturing
• scheduling and submitting material samples for analysis to internal and external laboratories
• coordinating, reviewing, and submitting testing results for materials for Quality disposition
• supporting Operational Excellence Initiatives
• all other applicable Incoming Quality functions.

• The Specialist role will be responsible for activities that support regulatory and cGMP compliance programs and initiatives to include the following:

• Performs thorough and timely inspection of components.
• Coordinates sample submission and schedules testing for chemicals to assure materials are within specification.
• Authors' standard operating procedures (SOPs) for the performance of Incoming Quality processes.
• Supports and contributes to investigations as needed and follows site procedures in the documentation of Quality Notifications and CAPAs within the deviation management program.
• Provides active support during audits and inspections (regulatory, internal, safety), as required.
• Executes raw material sampling and inspection procedures associated with media batch release.
• Supports site, divisional and Quality initiatives.
• Provides support to Packaging Operations through documentation review and clearance activities.
• Reviews and approves SOPs for Quality and supporting departments.
• Support operational excellence initiatives targeted to increase the speed, flexibility, and efficiency of Vaccine & Sterile Operations’ business processes.
• Able to assess Compendial requirements and updates for raw material and component testing
• Other duties as requested by management.
• Solves complex problems; takes a new perspective on existing solutions.
• Explains difficult issues and works to build alignment around a complex situation.
• Makes decisions within guidelines and policies which impact a range of standard and non-standard client, customer, operational, project or service activities
• Aware of costs and assists in controlling costs related to own work

• B.S. or B.A. degree in Science or Engineering
• Minimum 3 years experience in pharmaceutical operations, technical services, and/or quality operations
• Knowledge of CFR, Eudralex, USP and other regulatory guidance specific to the pharmaceutical industry
• Knowledge of Sampling plans, ANSI tables and AQLs
• Hands on experience with SAP and LIMs preferred
• BCG Production Medical Clearance

• 
  Position is full-time, Monday- Friday 8 am-5 pm
• May be requested to work on weekends, overtime, and holidays based on business needs.
• 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

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