Stability Study Reviewer
Eurofins USA BioPharma Services
Job Description
Job Description
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 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 is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins 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. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. 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.
Job DescriptionEurofins Lancaster Laboratories is seeking a highly analytical and quality‑driven Data Reviewer to ensure accuracy and compliance of all stability protocols and study builds prior to client release. This position plays a crucial role in safeguarding data integrity and ensuring that client expectations are consistently met.
This role includes a structured training progression: the individual will be fully trained as a Stability Protocol Reviewer prior to performing protocol and study review responsibilities. This ensures a deep understanding of both the technical content and system workflows that impact the quality of client deliverables.
Key Responsibilities
Training Phase – Protocol Writing & Study Building
- Complete comprehensive training in protocol writing based on Eurofins‑generated quotes.
- Learn and practice building stability studies within the LIMS system following client‑provided protocols.
- Develop proficiency in interpreting client requirements, scientific documentation, and stability program workflows.
Primary Role – Data Review
- Perform detailed, independent review of stability protocols and study builds to ensure accuracy, completeness, and alignment with client expectations.
- Confirm that all protocol parameters (e.g., storage conditions, pull points, test plans) are correctly entered and consistent with both quotes and client-provided documents.
- Verify compliance with GMP, internal SOPs, and industry guidelines.
- Identify discrepancies, errors, or gaps and communicate effectively with Protocol Writers, Project Managers, and other stakeholders to resolve issues.
- Ensure documentation is traceable, audit-ready, and maintained in accordance with data integrity principles (ALCOA+).
- Support continuous improvements in review workflows, documentation standards, and system utilization.
Required
- Bachelor’s degree in a scientific discipline (Chemistry, Biology, Pharmaceutical Sciences, or related field) or equivalent industry experience.
- Strong scientific comprehension and ability to interpret technical protocols, quotes, and study plans.
- Exceptional attention to detail and commitment to data accuracy.
- Strong communication skills with the ability to constructively collaborate and provide clear feedback.
- Experience or familiarity with GMP, data integrity expectations, and regulated laboratory environments.
- Ability to learn and work effectively within LIMS or similar informatics systems.
Position is full-time, Mon-Fri 8am-4pm. Candidates currently living within a commutable distance of Lancaster, 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 BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
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