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WuXi AppTec Technical Data Reviewer in St. Paul, Minnesota

WuXi AppTec US-MN-St. Paul Job ID 2021-8114 Overview The Technical Data Reviewer will review technical data for compliance to SOPs and methods and assure accuracy. The reviewer will have strong attention to detail and be quality oriented. Raw data and final analytical reports from various standardized and custom analytical techniques and wet chemistry will be reviewed. Responsibilities * Primary focus on review of standardized testing and custom studies:Familiar with the concepts and data outputs of various analytical instrumentation including but not limited to: GCMS, LCMS, ICP, SEM-EDS, DSC, FTIR, DLS, particle counts and wet chemistry. Verifies electronic data and written raw data to ensure accuracy and completeness of testing documentation according to methods, protocols/study designs, and /or SOPs. Ensures compliance to GDP/GMP expectations. Reviews routine/standard and custom final analysis reports and verifies the integrity and traceability of data reported. Performs verification of calculations via hand-calculations, computers, or validated spreadsheets. Understands and references USP * Participates in spreadsheet validation activities as needed. * Ability to present issues supported by solid rationale and evidence; collaborate and suggest solutions to enforce compliance. * Manage work queue and prioritize to meet customer timelines. * Interacts with technical study managers, project managers, and technical staff as required. * Able to navigate electronic systems (e.g. LIMS, environmental monitoring, Chromatographic Data Systems) to verify electronic data. * Facilitates corrections with analysts to ensure all records are complete and accurate. * Assist in SOP revisions as needed or required. * Contributes to the overall operations and to the achievement of departmental goals. * Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures. * Thorough understanding of Good Manufacturing Practices. * Assist in education, guiding and influencing scientific staff in regards GDP best practices. * Assist in mentoring and training new data reviewers as needed. * May be required to work Holidays and weekends. * May be required to assist in other departments. * Other duties as assigned. Qualifications Experience / Education * Minimum 1 year of review or quality control experience preferred * Bachelor's Degree in scientific field or related discipline * Minimum 3 years' experience working in a regulated environment * Life Science and/or Biotech laboratory experience preferred * Analytical chemistry / chromatography experience preferred Knowledge / Skills / Abilities: * Strong organizational skills with attention to detail * Proficient in Oral and Written communication skills * Need to be able to read, write and understand English * Proficient in Microsoft (Excel, Word, Outlook) * The ability to work in a fast-paced environment while managing priorities and maintaining deadlines for multiple projects. Physical Requirements: * Must be able to work in a Lab setting with exposure to animals/biohazards/chemical (list chemicals) * Must be able to wear appropriate PPE * Must be able to work in environment with minimal noise levels * Ability to stand for long periods of time * Clarity of vision * Ability to identify and distinguish colors * Must be able to perform activities with repetitive motions * Ability to lift 25 lbs occasionally * Ability to crouch, bend, twist and reach * Inside working conditions An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Emplo

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