Hiring: Quality Analyst II - Quality Batch Review/Disposition Company: Simtra BioPharma Solutions Location: Bloomington, IN Job Posted Time: 2026-09-15 13:51:40 Employment Type: Contract Target Skills & Keywords : Microsoft Excel, Quality Assurance About the job Experience: •At least 5 years of Pharmaceutical Quality or Manufacturing experience. Required Skills: •Perform batch record review and final product release / disposition for GMP batches produced at Simtra for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc. •Reconcile discrepancies with documentation and/or electronic systems as appropriate. •Plan, organize, evaluate, and communicate applicable activities of designated QA batch review functions, including Quality metrics reporting. •Initiate and Author batch record related Deviations. •Perform verification of Hold System activities. •Reconcile controlled forms in the Veeva system. •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 raised client issue resolution (conference calls, responding to batch record observations) Qualifications: •Bachelor’s degree in a science field with a minimum of 2 year Pharmaceutical Quality or Manufacturing experience, or Bachelor’s degree in non-science field with at least 5 years of Pharmaceutical Quality or Manufacturing experience. •Master’s degree in a science field with a minimum of 1 year Pharmaceutical Quality or Manufacturing experience, or Master’s degree in non-science field with at least 5 years of Pharmaceutical Quality or Manufacturing experience. •Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, 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 periods of time, but may involve walking or standing for periods of time. •In return, you’ll be eligible for [1] •2 year Pharmaceutical Quality or Manufacturing experience, or Bachelor’s degree in non-science field with at least 5 years of Pharmaceutical Quality or Manufacturing experience. •1 year Pharmaceutical Quality or Manufacturing experience, or Master’s degree in non-science field with at least 5 years of Pharmaceutical Quality or Manufacturing experience. 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!