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Bench Scientist I

Company name
The Ascent Services Group, Inc.

Andover, MA

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Job Description: Assist with quality control (QC) review of operational procedures performed within a large molecule bioanalytical group supporting regulated non-clinical and clinical studies. The scope will include QC review of various regulated software applications which are used in support of PK and immunogenicity method validations and sample analysis. Software applications utilized include electronic notebook, laboratory information management systems, and global documentation management systems for storage of submission-ready documents. Attention to detail to ensure accurate review of documented processes in a regulatory compliant manner. Expertise performing QC review (document verification, audit trail review) is highly desirable, preferably within the pharmaceutical industry. Knowledge and expertise working with software applications is highly desirable. Experience with report formatting is a plus. Ability to execute tasks with high quality against challenging time lines. Become proficient in various regulated software applications used within the regulated bioanalytical department to conduct QC review per established QC checklists. Utilize good documentation skills to collate QC observations and potential trends. Communicate project specific QC observations (written and verbal) to manager to identify items requiring corrective action \/ preventative action. Assist with document formatting as needed. 3 competencies: Experience performing QC review (document verification and audit trail review) Knowledge and expertise with regulated electronic systems\/software applications. Detail-oriented with good documentation skills. Position Comments visible to MSP and Supplier: old request 9923 , all new resumes

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The Ascent Services Group, Inc.

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