Senior Data Review Specialist

• 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 

• 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

 

 

• 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.