Hiring: Quality Analyst I (3rd shift) Company: Simtra BioPharma Solutions Location: Bloomington, IN Job Posted Time: 2026-09-16 14:51:35 Employment Type: Contract Target Skills & Keywords : Microsoft Excel, Quality Assurance About the job Required Skills: •Perform final batch record review •Reconcile discrepancies with documentation and/or electronic systems as appropriate. •Compile documentation packets for batch manufacturing, including printing of controlled forms and other serialized or controlled documentation that is not part of the effective manufacturing batch record. •As needed during operations, generate additional batch documents for batches in progress. This may include supplemental batch record sections, controlled forms, and documents of other types. •Manage the process of sign-out and sign-in of batch records. •Manage the process of correction resolution, assisting personnel with controlled access to executed records requiring documentation corrections. •Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions to ensure on-time Quality review of batch records in order to achieve internal targets and contractual commitments for batch release. •Participate in continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction. Qualifications: •Bachelor’s degree in a science discipline or bachelor’s degree in non-science discipline with at least three years of Pharmaceutical Quality or Manufacturing experience. •Demonstrated understanding of quality assurance in an FDA-regulated environment and aseptic processing operations. •Effective organizational, technical and problem-solving skills •Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.) •Must wear appropriate personal protective equipment as applicable •Duties may require overtime work, including nights and weekends •Use of hands and fingers to manipulate office equipment is required •Position requires sitting for long hours but may involve walking or standing for periods of time. •In return, you’ll be eligible for [1] Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!