Senior Data Review Specialist

Eurofins USA PSS Insourcing Solutions•Winston-Salem, NC

1d•Onsite

About The Position

Eurofins Scientific is an international life sciences company providing a unique range of analytical testing services. The Senior Data Review Specialist will apply GMP/GLP/ISO 17025 compliance standards in all areas of responsibility, demonstrating and promoting the company vision. This role requires strong client service skills, teamwork, and collaboration, with proactive planning to maximize productivity and meet quality and productivity metrics. Regular attendance, punctuality, and effective communication with clients, staff, and management are essential. The specialist will conduct all activities safely and efficiently, keep accurate records, follow instructions, and comply with company policies, while providing clear feedback. The core function involves performing Data Review of routine data from various laboratory methods including single and double analyte chromatography (GCMS, HVGC, LC), multi-analyte chromatography, smoke data, inorganics lab, wet chemistry, and microbiology lab analyses. This includes reviewing freeform notebooks and controlled forms using Good Documentation Practices (GDP), assessing analytical data for accuracy and compliance, and collaborating with QA and analysts. The role also involves completing monthly reports, leading capacity metrics and hot studies, developing and editing Work Instructions and SOPs, and performing complex calculations. A proficient understanding of laboratory instrumentation is also required.

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 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.
Proficient in Microsoft Office including Excel, PowerPoint, Outlook.
Proficient in LIMS.
Proficient in simple math including: Unit conversions, Standard calculations, Dilution factors, Dilution schemes.
Proficient in review of complex calculations on Microsoft Excel Spreadsheets.
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.

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.
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.