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 believes it is a global leader in food, environmental, 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 in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. 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, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

 In 2019, Eurofins generated total revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.

The IT Quality Technical Writer is responsible for translating regulatory and technical requirements, as defined by Eurofins businesses and Eurofins National Service Centre (NSC) IT Infrastructure, into clear concise GxP-compliant policies, procedures and protocols. 

Eurofins is seeking an IT Quality Technical Writer to help review, revise and create documentation to establish and maintain GxP compliance of its IT systems and applications. Specifically, this responsibility includes collaborating with Eurofins businesses and Eurofins NSC IT infrastructure to define requirements, drafting GxP-compliant documents (i.e. standard operating procedures, qualification/validation plans, test protocols and policies), ensuring technical and quality review is performed on all GxP documents, and managing in-flight or approved documents within the Eurofins document management system.

The Specialist actively promotes a GxP compliant culture and effective GxP document hierarchy within Eurofins NSC IT Infrastructure.  The objective is to ensure that the Eurofins National Service Centre (NSC) IT Infrastructure remains compliant through the development, implementation and maintenance of policies and procedures.

Essential Job Duties:

• Collaborate with Eurofins businesses and IT technical teams to define computerized system requirements and lifecycle activities;
• Draft, revise and review documents used to ensure GxP compliance of computerized systems throughout their lifecycle;
• Convey technical concepts into documents that may be consumed by the lay person;
• Maintain and monitor document statuses to ensure timely completion and facilitate meaningful reporting to management;
• Identify and implement continuous improvement opportunities for document development and management.

Other Assignments:

• Other assignments are made as needed. 

Minimum of 3-5 years of technical writing experience, preferably within an IT and/or GxP environment.

Required

• Bachelor’s degree or equivalent experience with an IT or technical writing background;
• Proven track record in application of GxP in service-oriented matrix organization;
• Communicate in a positive upbeat manner both verbally and in writing to a multicultural audience;
• Be receptive to internal politics;
• Fluent in English.
• Experience in understanding business requirements and aligning them with Information Security Policies;
• Experience in the execution of awareness programs.

Appreciated

• Experience in Pharma related regulations such as CFR part 11

Personal profile

• Very good communication skills (concise writing and orally convincing);
• Very good interpersonal relation skills;
• Ability to work in a complex international environment with a remote reporting line;
• Eager to learn and continuously develop personal and technical capabilities.

Education required:

• B.Sc. or M.Sc. in English, Information Technology, Information Security, or Quality Compliance;
• Languages: fluent English;

Position is Full Time, Monday - Friday 8:00am - 5:00pm. The role sits out of Lancaster, PA but DOES ALLOW REMOTE WORK. all candidates within Lancaster, PA commuting distance 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.