Senior Data Review Specialist

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