Senior Compliance Specialist & Technical Writer

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

• Lead technical-writing activities for the Compliance team, including procedures, process flows, regulatory and audit responses, and reports associated with trending, deviations, investigations, and validation.
• Lead quality-process improvements that strengthen GxP testing operations, systems, procedures, and documentation practices.
• Conduct detailed laboratory data and in-lab process reviews to support the integrity, accuracy, completeness, and quality of GxP data.
• Collaborate with Quality Assurance to maintain alignment with company policies and applicable federal regulations and support ongoing inspection readiness.
• Participate in regulatory inspections and internal Quality Assurance audits, including related preparation and follow-up activities.
• Monitor laboratory operations and quality metrics, identify trends, and drive related processes and procedural improvements.
• Evaluate system data integrity and end-to-end data flows, identify opportunities for enhancement and/or modernization, and participate in validation of computer and laboratory systems.
• Develop and/or update procedures supporting documentation reviews and process reviews.
• Lead training and coach department staff on adherence to SOPs, documentation requirements, procedures, assays, and laboratory systems.
• Participate in and/or lead internal initiatives that strengthen quality operations and support the setup of the new facility and laboratories.

Qualifications

• Expertise in technical writing, including reports and controlled procedures.
• Experience conducting, auditing, and supporting GxP laboratory documentation, protocols, and testing.
• Experience leading process-improvement efforts in laboratory, quality, and/or compliance settings.
• Experience training staff in procedures, assays, and laboratory systems.
• Experience operating in a GxP laboratory environment.
• Strong critical-thinking, troubleshooting, verbal-communication, and written-communication skills.
• Ability to follow procedures and thoroughly document laboratory work.
• Ability to work independently with limited supervision and meet project timelines.
• Strong attention to detail and the ability to manage multiple priorities.
• Adherence to applicable safety procedures in a BSL-2 laboratory.

Preferred Experience & Skills

• Experience in a GxP bioanalytical or clinical testing laboratory.
• Experience with Laboratory Information Management Systems, electronic laboratory notebooks, and other scientific applications.

Additional Information

Position is full-time, Mon-Fri 8am-5pm. Candidates currently living within a commutable distance of West Point, PA 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 USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.