Scientist II- Quality Assurance - 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 Organization 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 Organizations. It also has a rapidly developing presence in highly specialized 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 decentralized 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 2023, Eurofins generated total revenues of EUR 6.515 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Under general supervision, performs work that is varied and may be somewhat difficult in character. Audits and monitors various aspects of Eurofins Advantar Laboratories, Inc. for compliance with Good Manufacturing Practices (GMP) or in support of Good Laboratory Practices (GLP) by performing essential audits and training.
This position will require working and interacting with different employees of the company. In addition, a detailed oriented and team player person is essential for this position due to high volume of work. Knowledge of electronic documentation systems is a plus as this person may be involved in the deployment of new Part 11 electronic systems and other supporting systems. Must have the ability to apply acquired knowledge of Good Documentation Practice (GDP) and GMP to daily tasks. Knowledge of cGMP, GLP, Eudralex Volume 4, and ISO regulations are a plus.

Essential Duties, Activities, and Responsibilities:

• Applies GMP in all areas of responsibilities, as appropriate
• Demonstrates and promotes company vision
• Performs all QA functions in compliance with quality policy and regulatory requirements
• Audits a variety of methodologies as applied to various stages of pharmaceutical development
• Verifies accurate transcription of raw data into Reports, Certificate of Analysis, or Summary of Analysis
• Reviews laboratory data and executed batch records against Advantar procedures
• Follows and facilitates adherence to establish quality compliance measures and respective regulatory agencies, including FDA and EU GMPs
• Performs internal laboratory audits and keep management informed of identified findings
• Discusses compliance issues with responsible scientist, Project Director, or Area Management
• Interacts with clients as necessary to maintain and grow the business
• Regular attendance and punctuality
• Keeps current with project review, closeout, and archival
• Writes, formats, trains in Standard Operating Procedures and supports Quality Audits
• Attends training programs as needed to satisfy regulatory requirements
• Supports new quality initiatives and continuous improvements
• Conducts all activities in a safe and efficient manner
• Performs all other duties as assigned

Qualifications

Education/Experience:

• Bachelor's or Master's degree in Chemistry or closely related science field from a four year college/university or equivalent education and job experience; at least one year of previous employment history in a regulatory environment such as GMP/GLP, ISO or equivalent.

Ability and/or Skills:

• Solid understanding of chemistry/lab practices. Knowledge of auditing techniques
• Familiarity with at least one scientific technique (HPLC, GC, etc.)
• Proven ability/knowledge to work within the other groups of the company
• Planning, organization, and work management (multitasking); follow-up