Data Review Senior Specialist II

Eurofins PSS Insourcing Solutions; Winston-Salem (NC); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA PSS Insourcing Solutions is seeking a detail-oriented laboratory data reviewer to ensure GMP/GLP compliance and data integrity. The role emphasizes cross-functional collaboration, timely data reporting, and support for client projects within a highly regulated environment.

The ideal candidate has a strong scientific background, excellent documentation skills, and the ability to train staff while maintaining professional client-facing standards.

Qualifications

• Bachelor's degree in Chemistry, Biology, or related field, or equivalent experience.
• 7+ years of related experience.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Responsibilities

• Applies GMP/GLP in all areas of responsibility as appropriate.
• Demonstrates and promotes the company vision and client service skills.
• Performs data review and investigations in accordance with SOPs and regulatory requirements.
• Produces internal and client data reports; assists in technical writing and report writing.
• Maintains documentation accuracy and data integrity; trains personnel as needed.
• Interacts with laboratory staff and auditors to ensure data is properly reviewed and documented.

Skills

Microsoft Office

Laboratory skills

Team player

Writing skills

Independent

Detail oriented

Scientific background

Organizational skills

Communication skills

Education

Bachelor's degree in Chemistry, Biology, or related field

Tools

CDS

LIMS

Empower

OpenLab

Tiamo

Job 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

• Applies GMP/GLP in all areas of responsibility, as appropriate
• Applies the highest quality standard in all areas of responsibility
• Demonstrates and promotes the company vision
• Demonstrates strong client service skills, teamwork, and collaboration
• Proactively plans and multitasks to maximize productivity
• Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
• Regular attendance and punctuality
• Applies 17025 compliance standards in all areas of responsibility, as appropriate
• Possesses strong organizational skills
• Provides clear feedback
• Keeps accurate records, follows instructions, and complies with company policies
• Proactively checks and stays current with all training across multiple learning platforms
• Accepts responsibility for data integrity checks and defends all data approved
• Pays attention to details and remains very organized at all times
• Exhibits a high-level of professionalism and strong interpersonal skills
• Challenges others’ work without being intimidated, but able to remain professional
• Remains flexible and shift priorities quickly
• Produces internal routine and non-routine data reports for clients
• Reviews and audits the most complex and novel laboratory data one or more areas (including MDV) according to departmental, corporate and client SOPs, Work Instructions, and/or Forms; reads and understands analytical procedures
• Maintains the highest level of proficiency in terms of those duties and responsibilities as required auditors/data reviewers
• Performs mathematical calculations as part of data review
• Interacts both directly and indirectly with laboratory staff members to ensure all data review are appropriately and efficiently corrected and documented
• Assists with Technical Writing and/or Report Writing
• Assists in conducting laboratory investigations, exceptions, planned deviations, and/or corrective and preventative actions
• Assists in training of laboratory personnel
• Assists with Quality and Regulatory Audits and interact directly with auditors
• Maintains continuous learning to keep abreast if regulatory or industry standards as related to data review requirements
• Identifies potential quality system improvements to maximize quality and productivity
• Serves as SME in training of laboratory personnelli>
• Communicates effectively with client staff members
• Conducts all activities in a safe and efficient manner
• Performs other duties as assigned

Qualifications

• Strong computer skills; excellent proficiency in Microsoft Office, Word, Excel, PowerPoint, SharePoint
• Technical laboratory skills.
• Strong team player
• Strong writing skills
• Ability to work independently and maintain self-motivation
• Detail oriented
• Strong scientific background
• Strong organizational skills
• Strong communication skills in person.
• High level of professionalism; professional appearance as a client-interfacing ambassador of the company
• Strong customer-service orientation
• Familiarity with various computer software (CDS, LIMS, Empower, OpenLab, Tiamo, etc.)

Basic Minimum Qualifications

• Bachelor's degree in Chemistry, Biology, or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
• 7+ years of related experience
• Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information

• Position is Monday- Friday 8:00 AM- 5:00PM. Overtime as needed.
• May be requested to work on weekends, overtime, and holidays based on business needs
• Candidates currently living within a commutable distance of Winston-Salem, 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
• Authorization to work in the United States indefinitely without restriction or sponsorship

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.