Senior Associate, Research Operations-Quality Control

This individual will be a member of the local quality team that supports preclinical and clinical gene therapy research functions. The candidate will have a clear understanding of the data capture process and will be responsible for performing QC review of gene therapy research data including immunology and molecular assays, histology and morphometrics, and nonclinical study data, as well as tracking, trending, and reporting results. This individual will also be responsible for compiling, analyzing, and trending documentation issues, communicating to staff as necessary, and updating documentation as applicable. This individual may assist with other activities within the compliance group as needed.

• Compiling data for internal reporting
• Identifying and assisting with deviations
• Performing QC review of all data, worksheets, and records from GLP, GCLP, and R&D activities
• Assisting with identifying and mitigating gaps in procedures and practices
• Ensuring data integrity by reviewing forms for correctness and completeness, and managing corrections
• Assisting with identifying and mitigating deviations in procedures and practices
• Performing QC review of study protocols and reports

• Ability to multi-task and adapt quickly to a changing environment
• Strong writing and communication skills are required
• Minimum of 5 years of experience in a quality role is required, preferably in a GLP environment
• B.S. degree in Biology, Molecular Biology, Chemistry, or related field is required
• Experience in immunology, molecular genetics, histology, and/or nonclinical studies is preferred
• Minimum of 2 years of experience performing QC data review is required
• Experience in document control is preferable

#LI-OnsiteThe targeted salary range for this position is $83,500 - $104,500 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.