Training Specialist

August Bioservices is a privately‑owned Contract Development Manufacturing Organization (CDMO) based in Nashville, TN, providing drug discovery, formulation, and manufacturing services to pharma and biotech companies. We are expanding and seeking a Training Specialist to support our Training Program. Responsibilities Conduct New Hire Orientation training on Good Documentation Practices (GDP), ALCOA++ principles, and data integrity expectations. Coordinate and deliver instructor‑led training in classroom, practical, and on‑the‑job settings. Support onboarding, qualification, and ongoing development of manufacturing personnel. Conduct hands‑on qualification for foundational manufacturing activities, including line preparation, balances and scales, pH meter operation, solution preparation, material transfer, disinfecting of classified manufacturing areas, and other core processes. Facilitate retraining and remediation activities to address performance gaps, deviations, or compliance issues. Maintain training records in MasterControl, ensuring accuracy and inspection readiness. Coordinate qualification scheduling and monitor training and qualification completion. Assist in developing and revising training materials, qualification documents, assessments, and instructional content. Complete qualification to serve as backup instructor for the site’s three‑day aseptic manufacturing training program. Conduct routine behavioral and procedural observations in manufacturing areas as part of the Aseptic Observation Program. Enter observation data into dashboards or tracking systems to support trending, analysis, and continuous improvement. Assist with internal audits, client audits, and regulatory inspections by providing training documentation and demonstrating compliance. Identify and implement opportunities to improve training effectiveness, qualification efficiency, and employee competency. Perform other duties as assigned. Qualifications Bachelor’s degree in education, engineering, scientific field, or related field preferred. 2+ years of experience in pharmaceutical manufacturing, quality assurance, or training. Experience in aseptic manufacturing and contamination control preferred. Experience developing and delivering technical training preferred. Knowledge, Skills, & Abilities Working knowledge of current Good Manufacturing Practices (cGMP). Strong understanding of Good Documentation Practices and ALCOA++ principles. Excellent communication, presentation, and coaching skills. Strong organizational and documentation skills. Ability to evaluate trainee performance and provide constructive feedback. Ability to work effectively with employees at all organizational levels. Proficiency in Microsoft Word, Excel, and PowerPoint. Ability to work on flexible schedules, including off‑shift and weekend support as needed. Physical Requirements Prolonged periods of standing in a manufacturing area or sitting at a desk and working on a computer. Ability to lift, carry, push, or pull up to 40 lbs occasionally and up to 30 lbs frequently; two‑person lift or mechanical assist required for loads exceeding 50 lbs. Able to gown for Grade A/B, Grade C/D and wear a respirator without restrictions. Equal Employment Opportunity August Bioservices is an equal‑opportunity employer and values diversity. All aspects of employment—including the decision to hire, promote, discipline, or discharge—are based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of status protected under federal, state, or local law. #J-18808-Ljbffr