Senior Data Review Specialist

Eurofins USA PSS Insourcing Solutions•Winston-Salem, NC

13h•Onsite

About The Position

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across various industries to promote safety, health, and sustainability. Our laboratories work with major global companies to ensure product safety, ingredient authenticity, and accurate labeling. Eurofins is a global leader in food, environment, pharmaceutical, and cosmetic product testing, as well as agroscience Contract Research Organisation services. We also have a significant presence in specialized clinical diagnostics, in-vitro diagnostic products, and Contract Development and Manufacturing Organisations. Founded over 30 years ago, Eurofins has expanded from a single laboratory to a network of 900 laboratories in over 54 countries, employing 58,000 staff. We offer over 200,000 analytical methods to assess the safety, identity, composition, authenticity, origin, traceability, and purity of biological substances and products. In 2021, Eurofins achieved revenues of EUR 6.72 billion and has shown strong stock performance over the past two decades.

Requirements

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 related major).
Minimum of 4 years of experience in laboratory chromatography analyses, Quality, Regulatory, or related experience.
Authorization to work in the United States indefinitely without restriction or sponsorship.

Responsibilities

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.