Senior Data Review Specialist

Winston-Salem, NC, USA

Full-time

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

• Applies?GMP/GLP/ISO 17025?compliance standards?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?

• Communicate effectively with client, staff members, and?management?

• Communicates (oral and written) effectively and shows attention to detail

• Conducts all activities in a safe and efficient?manner?

• Performs other duties as?assigned?

• Keeps accurate records, follows instructions, and complies with company policies

• Provides clear feedback

• Performs Data Review of routine data described from the following:

• Single and double analyte chromatography methods from GCMS, HVGC, and LC labs

• Multi-analyte chromatography methods from GCMS, HVGC, and LC labs

• Smoke data from HP, Vapor, Combustible, and FSC

• Inorganics lab, wet chemistry

• Microbiology lab, SPOT, Enumeration, Water Activity, Endotoxin, b-glucan

• Perform Data Review of freeform notebooks and controlled forms using GDP

• Use current versions of SOPs and work instructions to perform Data Review

• Real-time documentation according to Good Documentation Practices

• Assess analytical data for accuracy and compliance

• Collaboration with QA and analysts to ensure proper documentation

• Proficient in Microsoft Office including Excel, PowerPoint, Outlook

• Complete Monthly reports regarding production, accomplishments, and difficulties

• Complete all assigned training on time

• Lead completion of Capacity metrics

• Lead Hot Studies

• Develop and edit Work Instructions and SOPs

• Proficient in simple math including:

• Unit conversions

• Standard calculations

• Dilution factors

• Dilution schemes

• Review of complex calculations on Microsoft Excel Spreadsheets

• Proficient in LIMS

• Proficient understanding of instrumentation used in the labs, including but not limited to:

• GC-FID/TCD

• GCMS

• LCMS, DAD, UV, RI, IC

• LC/MS/MS, GC/MS/MS

• TOF

• ICPMS, ICPOES

• Atomic Absorption

• pH

• KF- Karl Fisher

Qualifications

• Bachelor's degree in chemistry, biology, or other related degree concentration, or equivalent directly related experience (2 years of directly related industry experience is equivalent to 1 full-time year of college in a related major).

• Minimum of 4 years of experience in laboratory chromatography analyses, Quality, Regulatory, or related experience

• Experience in a cGMP and/or ISO 17025 environment

• Strong computer, scientific, and organizational skills

• Excellent communication (oral and written) and attention to detail

• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude

• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

• Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information

• The position is full-time, M- F 8 am to 5 pm

• May be requested to work on weekends, overtime, and holidays based on business needs.

• Candidates currently living within a commutable distance of Winston-Slem, 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

• #LI-EB1

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