
Data Review Senior Specialist II
Required skills
- GMP
- GLP
- 17025 compliance
- laboratory data
- SOPs
- Forms
- auditors
- data integrity
- mathematical calculations
- laboratory investigations
Nice to have
- Report Writing
- exceptions
- planned deviations
- corrective and preventative actions
- Quality and Regulatory Audits
- regulatory or industry standards
Role summary
Eurofins Scientific is seeking a Data Review Senior Specialist II to join their Pharmaceutical division in Winston-Salem, NC. This role involves applying GMP, GLP, and ISO 17025 compliance standards to review complex laboratory data, ensuring data integrity and adherence to SOPs. The specialist will perform mathematical calculations, assist with technical writing, investigations, and quality audits, and identify system improvements. The ideal candidate has 7+ years of related experience, a Bachelor's degree in a science field, strong computer skills (Microsoft Office, LIMS, etc.), and excellent organizational and communication abilities. This is a full-time, onsite position with comprehensive benefits.
Data Review Specialist responsibilities include, but are not limited to, the following:
- 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 personnel
- Communicates effectively with client staff members
- Conducts all activities in a safe and efficient manner
- Performs other duties as assigned
The ideal candidate would possess:
- 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
- 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.
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.
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