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