Senior Data Review Specialist

• AppliesGMP/GLP/ISO 17025compliance standardsin all areas ofresponsibility as appropriate 
• Applies the highest quality standard in all areas ofresponsibility 
• Demonstrates and promotes the companyvision 
• Demonstratesstrong client service skills teamwork andcollaboration 
• Proactively plans and multitasks to maximizeproductivity 
• Meetsall quality and productivity metricsanddemonstratesstrong teamwork andcollaboration 
• Regular attendance and punctuality 
• Communicate effectively with client staff members andmanagement 
• Communicates (oral and written) effectively and shows attention to detail 
• Conducts all activities in a safe and efficientmanner 
• Performs other duties asassigned 
• 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 :

• Bachelors degree in chemistry biology or other related degree concentration or equivalent directly related experience (2 years of directly related industry experience is equivalent to1 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

Additional Information :

• The position is full-time Monday through Friday 8 a.m. to 5 p.m..
• 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.
• Ability to work overtime as required.
• Ability to work overtime as required.
• 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
• #LI-EB1

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

Remote Work :

No

Employment Type :

Full-time