Quality Analyst I - Quality Batch Review

Simtra BioPharma Solutions - Bloomington, IN

Hiring: Quality Analyst I - Quality Batch Review 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 Required Skills: •The Quality Analyst I is a member of the Quality Assurance Team (QA) reporting directly to the Quality Manager or Supervisor, QA Batch Review. They perform review of all quality documentation generated during filling or packaging operations and effectively communicate with customer support departments. •Perform batch record review 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. •Facilitate an environment of partnership and communication between Quality Assurance, Production and other support functions to ensure timely 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. •Perform final batch record review, product release / disposition of GMP batches produced at Simtra •May require client or Regulatory Agency interaction Qualifications: •Bachelors degree required •Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Veeva, D365, Trackwise, etc.) •Duties may require overtime work, including nights and weekends •Use of hands and fingers to manipulate office equipment is required •Position may require standing for long 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!